BLA 103000

ALLERGAN

FDA Drug Application

Application #103000

Documents

• Letter: 2004-03-11
• Letter: 2004-07-21
• Letter: 2009-08-07
• Letter: 2010-10-20
• Letter: 2013-01-23
• Letter: 2012-11-14
• Letter: 2012-07-18
• Letter: 2015-08-12
• Letter: 2016-02-05
• Label: 2004-03-11
• Label: 2010-03-17
• Label: 2009-08-07
• Label: 2010-10-19
• Label: 2015-08-07
• Label: 2016-01-26
• Label: 2012-11-14
• Label: 2013-09-17
• Letter: 2004-03-11
• Letter: 2010-03-18
• Letter: 2009-08-07
• Letter: 2011-08-30
• Letter: 2015-08-10
• Letter: 2016-01-22
• Letter: 2013-09-13
• Letter: 2014-05-08
• Letter: 2015-04-21
• Label: 2004-09-15
• Label: 2009-08-07
• Label: 2011-08-30
• Label: 2011-07-08
• Label: 2013-01-23
• Label: 2015-04-21
• Label: 2015-08-12
• Review: 2004-03-11
• Review: 2004-03-11
• Review: 2013-10-23
• Review: 2013-08-09
• Review: 2015-09-23
• Other Important Information from FDA: 2008-08-12
• Label: 2017-04-05
• Label: 2017-04-05
• Label: 2017-04-05
• Letter: 2017-04-12
• Letter: 2017-04-12
• Letter: 2017-04-12
• Label: 2017-04-21
• Letter: 2017-04-21
• Review: 2017-05-17
• Label: 2017-10-03
• Letter: 2017-10-05
• Label: 2018-05-17
• Label: 2018-05-17
• Letter: 2018-05-21
• Letter: 2018-09-14
• Label: 2019-06-21
• Letter: 2019-06-21
• Label: 2019-10-21
• Medication Guide: 2019-10-21
• Letter: 2019-10-22
• Label: 2019-12-12
• Pediatric Medical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2020-07-17
• Letter: 2020-09-14
• Label: 2020-09-15
• Medication Guide: 2020-09-17
• Letter: 2020-10-20
• Label: 2020-10-20
• Medication Guide: 2020-10-20
• Label: 2021-02-09
• Medication Guide: 2021-02-09
• Letter: 2021-02-10
• Label: 2021-07-28
• Medication Guide: 2021-07-28
• Letter: 2021-07-29
• Label: 2022-08-25
• Medication Guide: 2022-08-25
• Letter: 2022-08-29

Application Sponsors

BLA 103000

ALLERGAN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	VIAL; SINGLE-USE	50 UNITS/VIAL	0	BOTOX	OnabotulinumtoxinA
002	VIAL; SINGLE-USE	100 UNITS/VIAL	0	BOTOX	OnabotulinumtoxinA
003	VIAL; SINGLE-USE	200 UNITS/VIAL	0	BOTOX	OnabotulinumtoxinA
004	VIAL; SINGLE-USE	50 UNITS/VIAL	0	BOTOX COSMETIC	OnabotulinumtoxinA
005	VIAL; SINGLE-USE	100 UNITS/VIAL	0	BOTOX COSMETIC	OnabotulinumtoxinA

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1991-12-09	UNKNOWN
EFFICACY; Efficacy	SUPPL	1004	AP	2000-12-21	UNKNOWN
EFFICACY; Efficacy	SUPPL	5000	AP	2002-04-12	STANDARD
EFFICACY; Efficacy	SUPPL	5050	AP	2004-07-19	STANDARD
LABELING; Labeling	SUPPL	5083	AP	2004-07-19	STANDARD
LABELING; Labeling	SUPPL	5092	AP	2005-02-01	STANDARD
S; Supplement	SUPPL	5097	AP	2005-03-11
S; Supplement	SUPPL	5101	AP	2005-04-14
LABELING; Labeling	SUPPL	5120	AP	2010-03-26	STANDARD
S; Supplement	SUPPL	5122	AP	2005-11-10
EFFICACY; Efficacy	SUPPL	5129	AP	2010-03-26	STANDARD
S; Supplement	SUPPL	5144	AP	2006-08-17
S; Supplement	SUPPL	5148	AP	2006-09-28
S; Supplement	SUPPL	5151	AP	2007-03-01
S; Supplement	SUPPL	5156	AP	2007-04-26
S; Supplement	SUPPL	5159	AP	2007-06-18
S; Supplement	SUPPL	5160	AP	2007-08-23
S; Supplement	SUPPL	5165	AP	2007-09-06
S; Supplement	SUPPL	5171	AP	2008-03-21
S; Supplement	SUPPL	5184	AP	2008-08-06
EFFICACY; Efficacy	SUPPL	5189	AP	2010-03-09	PRIORITY
S; Supplement	SUPPL	5197	AP	2009-08-21
LABELING; Labeling	SUPPL	5209	AP	2009-07-31	STANDARD
LABELING; Labeling	SUPPL	5210	AP	2009-07-31	STANDARD
EFFICACY; Efficacy	SUPPL	5215	AP	2010-10-15	STANDARD
S; Supplement	SUPPL	5219	AP	2010-06-03
EFFICACY; Efficacy	SUPPL	5232	AP	2011-08-24	STANDARD
S; Supplement	SUPPL	5236	AP	2011-06-23
LABELING; Labeling	SUPPL	5244	AP	2015-08-05	STANDARD
EFFICACY; Efficacy	SUPPL	5251	AP	2013-01-18	STANDARD
EFFICACY; Efficacy	SUPPL	5252	AP	2016-01-21	STANDARD
LABELING; Labeling	SUPPL	5253	AP	2012-11-09	STANDARD
LABELING; Labeling	SUPPL	5256	AP	2012-07-16	STANDARD
EFFICACY; Efficacy	SUPPL	5260	AP	2013-09-11	STANDARD
LABELING; Labeling	SUPPL	5280	AP	2014-05-07	STANDARD
EFFICACY; Efficacy	SUPPL	5282	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	5292	AP	2015-08-11	STANDARD
EFFICACY; Efficacy	SUPPL	5294	AP	2016-02-04	STANDARD
EFFICACY; Efficacy	SUPPL	5296	AP	2017-04-04	STANDARD
EFFICACY; Efficacy	SUPPL	5297	AP	2017-04-04	STANDARD
EFFICACY; Efficacy	SUPPL	5298	AP	2017-04-04	STANDARD
LABELING; Labeling	SUPPL	5302	AP	2017-04-20	STANDARD Label for BOTOX
EFFICACY; Efficacy	SUPPL	5303	AP	2017-10-02	STANDARD
LABELING; Labeling	SUPPL	5306	AP	2018-05-16	STANDARD
LABELING; Labeling	SUPPL	5307	AP	2018-05-15	STANDARD
EFFICACY; Efficacy	SUPPL	5308	AP	2018-09-12	STANDARD
EFFICACY; Efficacy	SUPPL	5309	AP	2019-06-20	PRIORITY
EFFICACY; Efficacy	SUPPL	5310	AP	2019-10-18	STANDARD
EFFICACY; Efficacy	SUPPL	5315	AP	2020-07-08	STANDARD
LABELING; Labeling	SUPPL	5317	AP	2020-09-13	STANDARD
EFFICACY; Efficacy	SUPPL	5318	AP	2021-02-09	STANDARD
EFFICACY; Efficacy	SUPPL	5320	AP	2021-07-28	STANDARD
	SUPPL	5322		0000-00-00

Submissions Property Types

SUPPL	1004	Orphan	5
SUPPL	5083	Null	15
SUPPL	5097	Null	0
SUPPL	5101	Null	0
SUPPL	5122	Null	0
SUPPL	5144	Null	0
SUPPL	5148	Null	0
SUPPL	5151	Null	0
SUPPL	5156	Null	0
SUPPL	5159	Null	0
SUPPL	5160	Null	0
SUPPL	5165	Null	0
SUPPL	5171	Null	0
SUPPL	5184	Null	0
SUPPL	5197	Null	0
SUPPL	5209	Null	7
SUPPL	5219	Null	0
SUPPL	5236	Null	0
SUPPL	5244	Null	15
SUPPL	5252	Null	33
SUPPL	5256	Null	7
SUPPL	5282	Null	7
SUPPL	5292	Null	15
SUPPL	5294	Null	15
SUPPL	5296	Null	7
SUPPL	5297	Null	15
SUPPL	5298	Null	6
SUPPL	5302	Null	6
SUPPL	5303	Null	7
SUPPL	5306	Null	6
SUPPL	5307	Null	6
SUPPL	5308	Null	6
SUPPL	5309	Null	7
SUPPL	5310	Null	15
SUPPL	5315	Null	7
SUPPL	5317	Null	7
SUPPL	5318	Null	15
SUPPL	5320	Null	7
SUPPL	5322	Null	7

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103000
            [companyName] => ALLERGAN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/103000s5310lbl.pdf#page=47"]
            [products] => [{"drugName":"BOTOX","activeIngredients":"OnabotulinumtoxinA","strength":"50 UNITS\/VIAL","dosageForm":"VIAL; SINGLE-USE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"BOTOX","activeIngredients":"OnabotulinumtoxinA","strength":"100 UNITS\/VIAL","dosageForm":"VIAL; SINGLE-USE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"BOTOX","activeIngredients":"OnabotulinumtoxinA","strength":"200 UNITS\/VIAL","dosageForm":"VIAL; SINGLE-USE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"BOTOX COSMETIC","activeIngredients":"OnabotulinumtoxinA","strength":"50 UNITS\/VIAL","dosageForm":"VIAL; SINGLE-USE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"BOTOX COSMETIC","activeIngredients":"OnabotulinumtoxinA","strength":"100 UNITS\/VIAL","dosageForm":"VIAL; SINGLE-USE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/18\/2019","submission":"SUPPL-5310","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103000s5310lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2019","submission":"SUPPL-5309","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103000s5309lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2018","submission":"SUPPL-5308","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103000s5308lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2018","submission":"SUPPL-5306","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103000s5306lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2018","submission":"SUPPL-5307","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103000s5307lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2018","submission":"SUPPL-5307","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103000s5307lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2017","submission":"SUPPL-5303","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103000s5303lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2017","submission":"SUPPL-5302","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103000s5302lbl.pdf\"}]","notes":"Label for BOTOX"},{"actionDate":"04\/04\/2017","submission":"SUPPL-5298","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103000s5296s5297s5298lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2017","submission":"SUPPL-5297","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103000s5296s5297s5298lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2017","submission":"SUPPL-5296","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103000s5296s5297s5298lbl.pdf\"}]","notes":""},{"actionDate":"01\/21\/2016","submission":"SUPPL-5252","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103000s5252lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2015","submission":"SUPPL-5292","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103000s5292lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2015","submission":"SUPPL-5244","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103000s5244lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2015","submission":"SUPPL-5282","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103000s5282lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2013","submission":"SUPPL-5260","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103000s5260lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2013","submission":"SUPPL-5251","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103000s5251lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2012","submission":"SUPPL-5253","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103000Orig1s5253lbl.pdf\"}]","notes":""},{"actionDate":"08\/24\/2011","submission":"SUPPL-5232","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103000s5232lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2011","submission":"SUPPL-5236","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103000s5236lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2010","submission":"SUPPL-5215","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103000s5215lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2010","submission":"SUPPL-5189","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103000s5189lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2009","submission":"SUPPL-5210","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/103000s5109s5210lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2009","submission":"SUPPL-5209","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/103000s5109s5210lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2004","submission":"SUPPL-5050","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103000s5050lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2002","submission":"SUPPL-5000","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/botuall041202LB.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/09\/1991","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/08\/2020","submission":"SUPPL-5315","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/18\/2019","submission":"SUPPL-5310","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103000s5310lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/103000Orig1s5310ltr.pdf\"}]","notes":">"},{"actionDate":"06\/20\/2019","submission":"SUPPL-5309","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103000s5309lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/103000Orig1s5309ltr.pdf\"}]","notes":">"},{"actionDate":"09\/12\/2018","submission":"SUPPL-5308","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103000s5308lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103000Orig1s5308ltr.pdf\"}]","notes":">"},{"actionDate":"05\/15\/2018","submission":"SUPPL-5307","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103000s5307lbl.pdf\"}]","notes":">"},{"actionDate":"05\/16\/2018","submission":"SUPPL-5306","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103000s5306lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103000Orig1s5306ltr.pdf\"}]","notes":">"},{"actionDate":"10\/02\/2017","submission":"SUPPL-5303","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103000s5303lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/103000Orig1s5303ltr.pdf\"}]","notes":">"},{"actionDate":"04\/20\/2017","submission":"SUPPL-5302","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103000s5302lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/103000Orig1s5302ltr.pdf\"}]","notes":"> Label for BOTOX"},{"actionDate":"04\/04\/2017","submission":"SUPPL-5298","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103000s5296s5297s5298lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/103000s5298ltr.pdf\"}]","notes":">"},{"actionDate":"04\/04\/2017","submission":"SUPPL-5297","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103000s5296s5297s5298lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/103000Orig1s5296,s5297s5298ltr.pdf\"}]","notes":">"},{"actionDate":"04\/04\/2017","submission":"SUPPL-5296","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103000s5296s5297s5298lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/103000Orig1s5296,s5297s5298ltr.pdf\"}]","notes":">"},{"actionDate":"02\/04\/2016","submission":"SUPPL-5294","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/103000Orig1s5294ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"08\/11\/2015","submission":"SUPPL-5292","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103000s5292lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103000Orig1s5292ltr.pdf\"}]","notes":">"},{"actionDate":"04\/17\/2015","submission":"SUPPL-5282","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103000s5282lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103000Orig1s5282ltr.pdf\"}]","notes":">"},{"actionDate":"05\/07\/2014","submission":"SUPPL-5280","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103000Orig1s5280ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/11\/2013","submission":"SUPPL-5260","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103000s5260lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/103000Orig1s5260ltr.pdf\"}]","notes":">"},{"actionDate":"07\/16\/2012","submission":"SUPPL-5256","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103000Orig1s5256ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"11\/09\/2012","submission":"SUPPL-5253","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103000Orig1s5253lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103000Orig1s5253ltr.pdf\"}]","notes":">"},{"actionDate":"01\/21\/2016","submission":"SUPPL-5252","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103000s5252lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/103000Orig1s5252ltr.pdf\"}]","notes":">"},{"actionDate":"01\/18\/2013","submission":"SUPPL-5251","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103000s5251lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/103000Orig1s5251ltr.pdf\"}]","notes":">"},{"actionDate":"08\/05\/2015","submission":"SUPPL-5244","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103000s5244lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103000Orig1s5244ltr.pdf\"}]","notes":">"},{"actionDate":"06\/23\/2011","submission":"SUPPL-5236","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103000s5236lbl.pdf\"}]","notes":">"},{"actionDate":"08\/24\/2011","submission":"SUPPL-5232","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103000s5232lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/103000s5232ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2011\\\/103000Orig1s5232.pdf\"}]","notes":">"},{"actionDate":"06\/03\/2010","submission":"SUPPL-5219","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/15\/2010","submission":"SUPPL-5215","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103000s5215lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/103000s5215ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2010\\\/103000Orig1s5215.pdf\"}]","notes":">"},{"actionDate":"07\/31\/2009","submission":"SUPPL-5210","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/103000s5109s5210lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2009\\\/103000s5209s5210ltr.pdf\"}]","notes":">"},{"actionDate":"07\/31\/2009","submission":"SUPPL-5209","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/103000s5109s5210lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2009\\\/103000s5209s5210ltr.pdf\"}]","notes":">"},{"actionDate":"08\/21\/2009","submission":"SUPPL-5197","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/09\/2010","submission":"SUPPL-5189","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103000s5189lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/103000s5189ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2010\\\/103000Orig1s5189.pdf\"}]","notes":">"},{"actionDate":"08\/06\/2008","submission":"SUPPL-5184","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/21\/2008","submission":"SUPPL-5171","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/06\/2007","submission":"SUPPL-5165","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/23\/2007","submission":"SUPPL-5160","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/18\/2007","submission":"SUPPL-5159","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/26\/2007","submission":"SUPPL-5156","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/01\/2007","submission":"SUPPL-5151","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/28\/2006","submission":"SUPPL-5148","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/17\/2006","submission":"SUPPL-5144","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/26\/2010","submission":"SUPPL-5129","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/10\/2005","submission":"SUPPL-5122","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/26\/2010","submission":"SUPPL-5120","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/14\/2005","submission":"SUPPL-5101","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/11\/2005","submission":"SUPPL-5097","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/01\/2005","submission":"SUPPL-5092","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/19\/2004","submission":"SUPPL-5083","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/19\/2004","submission":"SUPPL-5050","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103000s5050lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/biologics\\\/2004\\\/103000_5050ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2004\\\/103000Orig1s5050.pdf\"}]","notes":">"},{"actionDate":"04\/12\/2002","submission":"SUPPL-5000","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/botuall041202LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2002\\\/botuall041202L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20170113111252\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm080509.htm\"}]","notes":">"},{"actionDate":"12\/21\/2000","submission":"SUPPL-1004","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2000\\\/botaller122100L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20090119110807\\\/https:\\\/\\\/www.fda.gov\\\/cder\\\/biologics\\\/products\\\/botaller122100.htm\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-08
        )

)