ALLERGAN FDA Approval BLA 103000

BLA 103000

ALLERGAN

FDA Drug Application

Application #103000

Documents

Letter2004-03-11
Letter2004-07-21
Letter2009-08-07
Letter2010-10-20
Letter2013-01-23
Letter2012-11-14
Letter2012-07-18
Letter2015-08-12
Letter2016-02-05
Label2004-03-11
Label2010-03-17
Label2009-08-07
Label2010-10-19
Label2015-08-07
Label2016-01-26
Label2012-11-14
Label2013-09-17
Letter2004-03-11
Letter2010-03-18
Letter2009-08-07
Letter2011-08-30
Letter2015-08-10
Letter2016-01-22
Letter2013-09-13
Letter2014-05-08
Letter2015-04-21
Label2004-09-15
Label2009-08-07
Label2011-08-30
Label2011-07-08
Label2013-01-23
Label2015-04-21
Label2015-08-12
Review2004-03-11
Review2004-03-11
Review2013-10-23
Review2013-08-09
Review2015-09-23
Other Important Information from FDA2008-08-12
Label2017-04-05
Label2017-04-05
Label2017-04-05
Letter2017-04-12
Letter2017-04-12
Letter2017-04-12
Label2017-04-21
Letter2017-04-21
Review2017-05-17
Label2017-10-03
Letter2017-10-05
Label2018-05-17
Label2018-05-17
Letter2018-05-21
Letter2018-09-14
Label2019-06-21
Letter2019-06-21
Label2019-10-21
Medication Guide2019-10-21
Letter2019-10-22
Label2019-12-12
Pediatric Medical Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Statistical Review1900-01-01
Letter2020-07-17
Letter2020-09-14
Label2020-09-15
Medication Guide2020-09-17
Letter2020-10-20
Label2020-10-20
Medication Guide2020-10-20
Label2021-02-09
Medication Guide2021-02-09
Letter2021-02-10
Label2021-07-28
Medication Guide2021-07-28
Letter2021-07-29
Label2022-08-25
Medication Guide2022-08-25
Letter2022-08-29

Application Sponsors

BLA 103000ALLERGAN

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001VIAL; SINGLE-USE50 UNITS/VIAL0BOTOXOnabotulinumtoxinA
002VIAL; SINGLE-USE100 UNITS/VIAL0BOTOXOnabotulinumtoxinA
003VIAL; SINGLE-USE200 UNITS/VIAL0BOTOXOnabotulinumtoxinA
004VIAL; SINGLE-USE50 UNITS/VIAL0BOTOX COSMETICOnabotulinumtoxinA
005VIAL; SINGLE-USE100 UNITS/VIAL0BOTOX COSMETICOnabotulinumtoxinA

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1991-12-09UNKNOWN
EFFICACY; EfficacySUPPL1004AP2000-12-21UNKNOWN
EFFICACY; EfficacySUPPL5000AP2002-04-12STANDARD
EFFICACY; EfficacySUPPL5050AP2004-07-19STANDARD
LABELING; LabelingSUPPL5083AP2004-07-19STANDARD
LABELING; LabelingSUPPL5092AP2005-02-01STANDARD
S; SupplementSUPPL5097AP2005-03-11
S; SupplementSUPPL5101AP2005-04-14
LABELING; LabelingSUPPL5120AP2010-03-26STANDARD
S; SupplementSUPPL5122AP2005-11-10
EFFICACY; EfficacySUPPL5129AP2010-03-26STANDARD
S; SupplementSUPPL5144AP2006-08-17
S; SupplementSUPPL5148AP2006-09-28
S; SupplementSUPPL5151AP2007-03-01
S; SupplementSUPPL5156AP2007-04-26
S; SupplementSUPPL5159AP2007-06-18
S; SupplementSUPPL5160AP2007-08-23
S; SupplementSUPPL5165AP2007-09-06
S; SupplementSUPPL5171AP2008-03-21
S; SupplementSUPPL5184AP2008-08-06
EFFICACY; EfficacySUPPL5189AP2010-03-09PRIORITY
S; SupplementSUPPL5197AP2009-08-21
LABELING; LabelingSUPPL5209AP2009-07-31STANDARD
LABELING; LabelingSUPPL5210AP2009-07-31STANDARD
EFFICACY; EfficacySUPPL5215AP2010-10-15STANDARD
S; SupplementSUPPL5219AP2010-06-03
EFFICACY; EfficacySUPPL5232AP2011-08-24STANDARD
S; SupplementSUPPL5236AP2011-06-23
LABELING; LabelingSUPPL5244AP2015-08-05STANDARD
EFFICACY; EfficacySUPPL5251AP2013-01-18STANDARD
EFFICACY; EfficacySUPPL5252AP2016-01-21STANDARD
LABELING; LabelingSUPPL5253AP2012-11-09STANDARD
LABELING; LabelingSUPPL5256AP2012-07-16STANDARD
EFFICACY; EfficacySUPPL5260AP2013-09-11STANDARD
LABELING; LabelingSUPPL5280AP2014-05-07STANDARD
EFFICACY; EfficacySUPPL5282AP2015-04-17STANDARD
LABELING; LabelingSUPPL5292AP2015-08-11STANDARD
EFFICACY; EfficacySUPPL5294AP2016-02-04STANDARD
EFFICACY; EfficacySUPPL5296AP2017-04-04STANDARD
EFFICACY; EfficacySUPPL5297AP2017-04-04STANDARD
EFFICACY; EfficacySUPPL5298AP2017-04-04STANDARD
LABELING; LabelingSUPPL5302AP2017-04-20STANDARD Label for BOTOX
EFFICACY; EfficacySUPPL5303AP2017-10-02STANDARD
LABELING; LabelingSUPPL5306AP2018-05-16STANDARD
LABELING; LabelingSUPPL5307AP2018-05-15STANDARD
EFFICACY; EfficacySUPPL5308AP2018-09-12STANDARD
EFFICACY; EfficacySUPPL5309AP2019-06-20PRIORITY
EFFICACY; EfficacySUPPL5310AP2019-10-18STANDARD
EFFICACY; EfficacySUPPL5315AP2020-07-08STANDARD
LABELING; LabelingSUPPL5317AP2020-09-13STANDARD
EFFICACY; EfficacySUPPL5318AP2021-02-09STANDARD
EFFICACY; EfficacySUPPL5320AP2021-07-28STANDARD
SUPPL53220000-00-00

Submissions Property Types

SUPPL1004Orphan5
SUPPL5083Null15
SUPPL5097Null0
SUPPL5101Null0
SUPPL5122Null0
SUPPL5144Null0
SUPPL5148Null0
SUPPL5151Null0
SUPPL5156Null0
SUPPL5159Null0
SUPPL5160Null0
SUPPL5165Null0
SUPPL5171Null0
SUPPL5184Null0
SUPPL5197Null0
SUPPL5209Null7
SUPPL5219Null0
SUPPL5236Null0
SUPPL5244Null15
SUPPL5252Null33
SUPPL5256Null7
SUPPL5282Null7
SUPPL5292Null15
SUPPL5294Null15
SUPPL5296Null7
SUPPL5297Null15
SUPPL5298Null6
SUPPL5302Null6
SUPPL5303Null7
SUPPL5306Null6
SUPPL5307Null6
SUPPL5308Null6
SUPPL5309Null7
SUPPL5310Null15
SUPPL5315Null7
SUPPL5317Null7
SUPPL5318Null15
SUPPL5320Null7
SUPPL5322Null7

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
        )

)

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