Treats overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and…. BLA 103000, held by Allergan. OnabotulinumtoxinA.
As of Nov 13, 2026, BLA 103000 (Botox, Botox Cosmetic), held by Allergan, was first approved by FDA on Dec 9, 1991, with 59 approved supplements and 0 published complete response letters.
BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 18, 2024 | Supplement 5331Efficacy (new indication or use) · Standard review | Approved | |
| Aug 11, 2023 | Supplement 5325Efficacy (new indication or use) · Standard review | Approved | |
| Jul 28, 2021 | Supplement 5320Efficacy (new indication or use) · Standard review | Approved | |
| Feb 9, 2021 | Supplement 5318Efficacy (new indication or use) · Standard review | Approved | |
| Jul 8, 2020 | Supplement 5315Efficacy (new indication or use) · Standard review | Approved | |
| Oct 18, 2019 | Supplement 5310Efficacy (new indication or use) · Standard review | Approved | |
| Jun 20, 2019 | Supplement 5309Efficacy (new indication or use) · Priority review | Approved | |
| Sep 12, 2018 | Supplement 5308Efficacy (new indication or use) · Standard review | Approved | |
| Oct 2, 2017 | Supplement 5303Efficacy (new indication or use) · Standard review | Approved | |
| Apr 4, 2017 | Supplement 5296Efficacy (new indication or use) · Standard review | Approved | |
| Apr 4, 2017 | Supplement 5297Efficacy (new indication or use) · Standard review | Approved | |
| Apr 4, 2017 | Supplement 5298Efficacy (new indication or use) · Standard review | Approved | |
| Feb 4, 2016 | Supplement 5294Efficacy (new indication or use) · Standard review | Approved | |
| Jan 21, 2016 | Supplement 5252Efficacy (new indication or use) · Standard review | Approved | |
| Apr 17, 2015 | Supplement 5282Efficacy (new indication or use) · Standard review | Approved | |
| Sep 11, 2013 | Supplement 5260Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2013 | Supplement 5251Efficacy (new indication or use) · Standard review | Approved | |
| Aug 24, 2011 | Supplement 5232Efficacy (new indication or use) · Standard review | Approved | |
| Oct 15, 2010 | Supplement 5215Efficacy (new indication or use) · Standard review | Approved | |
| Mar 26, 2010 | Supplement 5129Efficacy (new indication or use) · Standard review | Approved | None posted |
| Mar 9, 2010 | Supplement 5189Efficacy (new indication or use) · Priority review | Approved | |
| Jul 19, 2004 | Supplement 5050Efficacy (new indication or use) · Standard review | Approved | |
| Apr 12, 2002 | Supplement 5000Efficacy (new indication or use) · Standard review | Approved | |
| Dec 21, 2000 | Supplement 1004Efficacy (new indication or use) | Approved | |
| Dec 9, 1991 | Original applicationNew molecular entity | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Botox50 UNITS/VIAL · vial; single-use | OnabotulinumtoxinA | Rx |
| Botox100 UNITS/VIAL · vial; single-use | OnabotulinumtoxinA | Rx |
| Botox200 UNITS/VIAL · vial; single-use | OnabotulinumtoxinA | Rx |
| Botox Cosmetic50 UNITS/VIAL · vial; single-use | OnabotulinumtoxinA | Rx |
| Botox Cosmetic100 UNITS/VIAL · vial; single-use | OnabotulinumtoxinA | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 18, 2024 | Supplement 5316Labeling · Standard review | Approved | |
| Oct 18, 2024 | Supplement 5319Labeling · Standard review | Approved | |
| Oct 18, 2024 | Supplement 5323Labeling · Standard review | Approved | |
| Oct 18, 2024 | Supplement 5326Labeling · Standard review | Approved | |
| Oct 18, 2024 | Supplement 5331Efficacy (new indication or use) · Standard review | Approved | |
| Aug 11, 2023 | Supplement 5325Efficacy (new indication or use) · Standard review | Approved | |
| Aug 10, 2023 | Supplement 5327Labeling · Standard review | Approved | |
| Aug 22, 2022 | Supplement 5322Labeling · Standard review | Approved | |
| Jul 28, 2021 | Supplement 5320Efficacy (new indication or use) · Standard review | Approved | |
| Feb 9, 2021 | Supplement 5318Efficacy (new indication or use) · Standard review | Approved | |
| Sep 13, 2020 | Supplement 5317Labeling · Standard review | Approved | |
| Jul 8, 2020 | Supplement 5315Efficacy (new indication or use) · Standard review | Approved | |
| Oct 18, 2019 | Supplement 5310Efficacy (new indication or use) · Standard review | Approved | |
| Jun 20, 2019 | Supplement 5309Efficacy (new indication or use) · Priority review | Approved | |
| Sep 12, 2018 | Supplement 5308Efficacy (new indication or use) · Standard review | Approved | |
| May 16, 2018 | Supplement 5306Labeling · Standard review | Approved | |
| May 15, 2018 | Supplement 5307Labeling · Standard review | Approved | |
| Oct 2, 2017 | Supplement 5303Efficacy (new indication or use) · Standard review | Approved | |
| Apr 20, 2017 | Supplement 5302Labeling · Standard review | Approved | |
| Apr 4, 2017 | Supplement 5296Efficacy (new indication or use) · Standard review | Approved | |
| Apr 4, 2017 | Supplement 5297Efficacy (new indication or use) · Standard review | Approved | |
| Apr 4, 2017 | Supplement 5298Efficacy (new indication or use) · Standard review | Approved | |
| Feb 4, 2016 | Supplement 5294Efficacy (new indication or use) · Standard review | Approved | |
| Jan 21, 2016 | Supplement 5252Efficacy (new indication or use) · Standard review | Approved | |
| Aug 11, 2015 | Supplement 5292Labeling · Standard review | Approved | |
| Aug 5, 2015 | Supplement 5244Labeling · Standard review | Approved | |
| Apr 17, 2015 | Supplement 5282Efficacy (new indication or use) · Standard review | Approved | |
| May 7, 2014 | Supplement 5280Labeling · Standard review | Approved | |
| Sep 11, 2013 | Supplement 5260Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2013 | Supplement 5251Efficacy (new indication or use) · Standard review | Approved | |
| Nov 9, 2012 | Supplement 5253Labeling · Standard review | Approved | |
| Jul 16, 2012 | Supplement 5256Labeling · Standard review | Approved | |
| Aug 24, 2011 | Supplement 5232Efficacy (new indication or use) · Standard review | Approved | |
| Jun 23, 2011 | Supplement 5236 | Approved | |
| Oct 15, 2010 | Supplement 5215Efficacy (new indication or use) · Standard review | Approved | |
| Jun 3, 2010 | Supplement 5219 | Approved | None posted |
| Mar 26, 2010 | Supplement 5120Labeling · Standard review | Approved | None posted |
| Mar 26, 2010 | Supplement 5129Efficacy (new indication or use) · Standard review | Approved | None posted |
| Mar 9, 2010 | Supplement 5189Efficacy (new indication or use) · Priority review | Approved | |
| Aug 21, 2009 | Supplement 5197 | Approved | None posted |
| Jul 31, 2009 | Supplement 5209Labeling · Standard review | Approved | |
| Jul 31, 2009 | Supplement 5210Labeling · Standard review | Approved | |
| Aug 6, 2008 | Supplement 5184 | Approved | None posted |
| Mar 21, 2008 | Supplement 5171 | Approved | None posted |
| Sep 6, 2007 | Supplement 5165 | Approved | None posted |
| Aug 23, 2007 | Supplement 5160 | Approved | None posted |
| Jun 18, 2007 | Supplement 5159 | Approved | None posted |
| Apr 26, 2007 | Supplement 5156 | Approved | None posted |
| Mar 1, 2007 | Supplement 5151 | Approved | None posted |
| Sep 28, 2006 | Supplement 5148 | Approved | None posted |
| Aug 17, 2006 | Supplement 5144 | Approved | None posted |
| Nov 10, 2005 | Supplement 5122 | Approved | None posted |
| Apr 14, 2005 | Supplement 5101 | Approved | None posted |
| Mar 11, 2005 | Supplement 5097 | Approved | None posted |
| Feb 1, 2005 | Supplement 5092Labeling · Standard review | Approved | None posted |
| Jul 19, 2004 | Supplement 5050Efficacy (new indication or use) · Standard review | Approved | |
| Jul 19, 2004 | Supplement 5083Labeling · Standard review | Approved | None posted |
| Apr 12, 2002 | Supplement 5000Efficacy (new indication or use) · Standard review | Approved | |
| Dec 21, 2000 | Supplement 1004Efficacy (new indication or use) | Approved | |
| Dec 9, 1991 | Original applicationNew molecular entity | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
