ABBVIE INC FDA Approval BLA 125057

Application #125057

Documents

Letter	2004-03-16
Letter	2004-07-07
Letter	2005-10-20
Letter	2006-11-14
Letter	2007-03-06
Letter	2007-08-01
Letter	2006-11-14
Letter	2010-10-19
Letter	2012-10-03
Letter	2012-01-05
Letter	2012-01-05
Letter	2012-01-05
Letter	2012-05-30
Letter	2015-01-08
Letter	2013-05-15
Letter	2014-09-25
Letter	2014-05-20
Letter	2015-11-24
Letter	2016-07-01
Label	2005-10-10
Label	2006-11-14
Label	2007-07-31
Label	2006-11-14
Label	2008-02-26
Label	2011-03-04
Label	2012-05-29
Label	2013-05-13
Label	2013-04-29
Label	2013-09-24
Label	2014-09-26
Label	2014-06-03
Label	2014-05-15
Review	2015-03-09
Review	2015-03-09
Review	2013-04-09
Review	2016-02-03
Summary Review	2009-03-24
Letter	2004-08-06
Letter	2005-10-20
Letter	2007-02-23
Letter	2007-09-07
Letter	2008-01-25
Letter	2008-02-26
Letter	2011-03-25
Letter	2010-06-17
Letter	2009-12-03
Letter	2010-08-03
Letter	2011-09-13
Letter	2013-09-20
Letter	2014-02-27
Letter	2014-06-03
Letter	2014-10-02
Letter	2015-09-14
Label	2004-03-16
Label	2004-08-06
Label	2005-10-10
Label	2007-02-23
Label	2006-08-31
Label	2007-03-07
Label	2007-09-07
Label	2008-03-27
Label	2010-02-23
Label	2012-10-02
Label	2012-03-15
Label	2014-02-27
Label	2014-10-02
Label	2015-11-25
Label	2016-07-05
Review	2004-03-16
Review	2015-03-11
Review	2013-09-09
Review	2009-03-24
Review	2016-07-28
Other Important Information from FDA	2011-12-20
Summary Review	2016-03-11
Review	2014-12-24
Label	2017-03-28
Letter	2017-03-29
Label	2017-04-26
Label	2017-05-01
Letter	2017-05-02
Review	2017-05-17
Review	2017-05-17
Label	2017-10-24
Letter	2017-12-15
Label	2017-12-22
Medication Guide	2017-12-22
Pediatric Medical Review	1900-01-01
Pediatric Clinical Pharmacology Review	1900-01-01
Pediatric Statistical Review	1900-01-01
Letter	2018-08-03
Label	2018-08-03
Letter	2018-10-01
Label	2018-10-03
Letter	2018-10-17
Label	2018-10-18
Medication Guide	2018-10-18
Label	2018-12-07
Letter	2018-12-07
Letter	2019-01-18
Review	2019-06-03
Label	2019-06-06
Letter	2020-03-12
Label	2020-03-12
Letter	2020-12-21
Letter	2020-12-21
Label	2020-12-21
Label	2020-12-21
Medication Guide	2020-12-21
Medication Guide	2020-12-21
Letter	2021-02-25
Label	2021-02-25
Medication Guide	2021-02-25
Pediatric Medical Review	1900-01-01
Review	2021-04-07

Application Sponsors

BLA 125057

ABBVIE INC

Marketing Status

Prescription	001
Prescription	002

Application Products

001	SYRINGE	40MG/0.8ML	0	HUMIRA	ADALIMUMAB
002	VIAL	40MG/0.8ML	0	HUMIRA	ADALIMUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2002-12-31	STANDARD
LABELING; Labeling	SUPPL	4	AP	2003-09-12	STANDARD
EFFICACY; Efficacy	SUPPL	16	AP	2004-07-30	STANDARD
S; Supplement	SUPPL	23	AP	2004-06-18
EFFICACY; Efficacy	SUPPL	45	AP	2005-10-03	STANDARD
EFFICACY; Efficacy	SUPPL	46	AP	2005-10-03	STANDARD
EFFICACY; Efficacy	SUPPL	60	AP	2007-02-16	STANDARD
EFFICACY; Efficacy	SUPPL	62	AP	2006-07-28	STANDARD
LABELING; Labeling	SUPPL	65	AP	2006-06-23	STANDARD
EFFICACY; Efficacy	SUPPL	71	AP	2006-11-09	STANDARD
EFFICACY; Efficacy	SUPPL	89	AP	2007-02-27	PRIORITY
EFFICACY; Efficacy	SUPPL	94	AP	2007-07-30	STANDARD
EFFICACY; Efficacy	SUPPL	95	AP	2006-11-09	STANDARD
LABELING; Labeling	SUPPL	108	AP	2007-09-05	STANDARD
EFFICACY; Efficacy	SUPPL	110	AP	2008-01-18	STANDARD
EFFICACY; Efficacy	SUPPL	114	AP	2008-02-21	STANDARD
LABELING; Labeling	SUPPL	128	AP	2011-03-14	STANDARD
LABELING; Labeling	SUPPL	141	AP	2009-03-11	STANDARD
LABELING; Labeling	SUPPL	161	AP	2010-04-08	STANDARD
LABELING; Labeling	SUPPL	196	AP	2010-11-18	STANDARD
LABELING; Labeling	SUPPL	213	AP	2010-07-29	STANDARD
EFFICACY; Efficacy	SUPPL	215	AP	2011-02-25	STANDARD
LABELING; Labeling	SUPPL	224	AP	2010-09-29	STANDARD
EFFICACY; Efficacy	SUPPL	232	AP	2012-09-28	STANDARD
LABELING; Labeling	SUPPL	254	AP	2011-07-13	STANDARD
LABELING; Labeling	SUPPL	255	AP	2011-09-07	STANDARD
LABELING; Labeling	SUPPL	271	AP	2011-12-13	STANDARD
LABELING; Labeling	SUPPL	276	AP	2011-12-26	STANDARD
LABELING; Labeling	SUPPL	278	AP	2012-05-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	280	AP	2014-12-24
LABELING; Labeling	SUPPL	310	AP	2013-05-13	STANDARD
LABELING; Labeling	SUPPL	322	AP	2013-04-24	STANDARD
LABELING; Labeling	SUPPL	327	AP	2013-09-19	STANDARD
LABELING; Labeling	SUPPL	355	AP	2014-02-26	STANDARD
EFFICACY; Efficacy	SUPPL	356	AP	2014-09-23	STANDARD
LABELING; Labeling	SUPPL	366	AP	2014-05-30	STANDARD
EFFICACY; Efficacy	SUPPL	367	AP	2014-09-30	STANDARD
LABELING; Labeling	SUPPL	368	AP	2014-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	381	AP	2014-08-07
LABELING; Labeling	SUPPL	384	AP	2014-10-29	STANDARD
LABELING; Labeling	SUPPL	390	AP	2014-11-06	STANDARD
EFFICACY; Efficacy	SUPPL	393	AP	2015-09-09	STANDARD
EFFICACY; Efficacy	SUPPL	394	AP	2015-11-23	STANDARD
EFFICACY; Efficacy	SUPPL	397	AP	2016-06-30	STANDARD
EFFICACY; Efficacy	SUPPL	399	AP	2017-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	400	AP	2016-10-17	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	401	AP	2017-04-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	402	AP	2017-04-28	STANDARD
LABELING; Labeling	SUPPL	403	AP	2017-12-14	STANDARD
EFFICACY; Efficacy	SUPPL	406	AP	2018-08-02	STANDARD
EFFICACY; Efficacy	SUPPL	408	AP	2018-09-28	STANDARD
EFFICACY; Efficacy	SUPPL	409	AP	2018-10-16	STANDARD
LABELING; Labeling	SUPPL	410	AP	2018-12-06	STANDARD
LABELING; Labeling	SUPPL	411	AP	2019-01-11	STANDARD
LABELING; Labeling	SUPPL	415	AP	2020-03-11	STANDARD
EFFICACY; Efficacy	SUPPL	417	AP	2021-02-24	STANDARD
LABELING; Labeling	SUPPL	418	AP	2020-12-16	STANDARD
EFFICACY; Efficacy	SUPPL	419	AP	2020-12-16	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	23	Null	14
SUPPL	89	Null	2
SUPPL	114	Orphan	5
SUPPL	232	Null	7
SUPPL	254	Null	7
SUPPL	271	Null	7
SUPPL	280	Null	14
SUPPL	356	Null	6
SUPPL	367	Null	6
SUPPL	381	Null	14
SUPPL	384	Null	7
SUPPL	390	Null	15
SUPPL	393	Null	7
SUPPL	394	Null	15
SUPPL	397	Orphan	5
SUPPL	399	Null	6
SUPPL	403	Null	7
SUPPL	406	Null	15
SUPPL	408	Null	15
SUPPL	409	Null	6
SUPPL	410	Null	6
SUPPL	411	Null	15
SUPPL	415	Null	15
SUPPL	417	Null	15
SUPPL	418	Null	7
SUPPL	419	Null	7

CDER Filings

ABBVIE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125057
            [companyName] => ABBVIE INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/125057s409lbl.pdf#page=56"]
            [products] => [{"drugName":"HUMIRA","activeIngredients":"ADALIMUMAB","strength":"40MG\/0.8ML","dosageForm":"SYRINGE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"HUMIRA","activeIngredients":"ADALIMUMAB","strength":"40MG\/0.8ML","dosageForm":"VIAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/11\/2020","submission":"SUPPL-415","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125057s415lbl.pdf\"}]","notes":""},{"actionDate":"01\/11\/2019","submission":"SUPPL-411","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125057Orig1s411lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2018","submission":"SUPPL-410","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125057s410lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2018","submission":"SUPPL-409","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125057s409lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2018","submission":"SUPPL-408","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125057s408lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2018","submission":"SUPPL-406","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125057s406lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2017","submission":"SUPPL-403","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125057s403lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2017","submission":"SUPPL-402","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125057s402lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"04\/21\/2017","submission":"SUPPL-401","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125057s401lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2017","submission":"SUPPL-399","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125057s399lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2016","submission":"SUPPL-400","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125057s400lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"06\/30\/2016","submission":"SUPPL-397","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125057s397lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2015","submission":"SUPPL-394","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125057s394lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2014","submission":"SUPPL-367","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125057s367lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2014","submission":"SUPPL-356","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125057s356lbl.pdf\"}]","notes":""},{"actionDate":"05\/30\/2014","submission":"SUPPL-366","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125057s366lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2014","submission":"SUPPL-368","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125057s368lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2014","submission":"SUPPL-355","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125057Orig1s355lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2013","submission":"SUPPL-327","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125057s327lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2013","submission":"SUPPL-310","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125057s310lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2013","submission":"SUPPL-322","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125057s322lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2012","submission":"SUPPL-232","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125057s232lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2012","submission":"SUPPL-278","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125057s0278lbl.pdf\"}]","notes":""},{"actionDate":"12\/26\/2011","submission":"SUPPL-276","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125057s0276lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2011","submission":"SUPPL-215","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125057s0215lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2010","submission":"SUPPL-196","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125057s196lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2008","submission":"SUPPL-114","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125057s114lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2008","submission":"SUPPL-110","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125057s0110lbl.pdf\"}]","notes":""},{"actionDate":"09\/05\/2007","submission":"SUPPL-108","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125057s108lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2007","submission":"SUPPL-94","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125057s094_LBL.pdf\"}]","notes":""},{"actionDate":"02\/27\/2007","submission":"SUPPL-89","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125057s089Lbl.pdf\"}]","notes":""},{"actionDate":"02\/16\/2007","submission":"SUPPL-60","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125057s060LBL.pdf\"}]","notes":""},{"actionDate":"11\/09\/2006","submission":"SUPPL-95","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"11\/09\/2006","submission":"SUPPL-71","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"07\/28\/2006","submission":"SUPPL-62","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/125057s062lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2005","submission":"SUPPL-46","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/125057s0045,0046lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2005","submission":"SUPPL-45","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/125057s0045,0046lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2004","submission":"SUPPL-16","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/125057_0016lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/adalabb123102LB.htm\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/31\/2002","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/adalabb123102LB.htm\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2002\\\/adalabb123102L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2002\\\/125057_toc.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/11\/2020","submission":"SUPPL-415","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125057s415lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125057Orig1s415ltr.pdf\"}]","notes":">"},{"actionDate":"01\/11\/2019","submission":"SUPPL-411","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125057Orig1s411lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125057Orig1s411ltr.pdf\"}]","notes":">"},{"actionDate":"12\/06\/2018","submission":"SUPPL-410","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125057s410lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125057s410ltr.pdf\"}]","notes":">"},{"actionDate":"10\/16\/2018","submission":"SUPPL-409","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125057s409lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125057Orig1s409ltr.pdf\"}]","notes":">"},{"actionDate":"09\/28\/2018","submission":"SUPPL-408","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125057s408lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125057Orig1s408ltr.pdf\"}]","notes":">"},{"actionDate":"08\/02\/2018","submission":"SUPPL-406","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125057s406lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125057Orig1s406ltr.pdf\"}]","notes":">"},{"actionDate":"12\/14\/2017","submission":"SUPPL-403","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125057s403lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125057Orig1s403ltr.pdf\"}]","notes":">"},{"actionDate":"04\/28\/2017","submission":"SUPPL-402","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125057s402lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125057Orig1s402ltr.pdf\"}]","notes":">"},{"actionDate":"04\/21\/2017","submission":"SUPPL-401","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125057s401lbl.pdf\"}]","notes":">"},{"actionDate":"10\/17\/2016","submission":"SUPPL-400","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125057s400lbl.pdf\"}]","notes":">"},{"actionDate":"03\/27\/2017","submission":"SUPPL-399","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125057s399lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125057Orig1s399ltr.pdf\"}]","notes":">"},{"actionDate":"06\/30\/2016","submission":"SUPPL-397","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125057s397lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125057Orig1s397ltr.pdf\"}]","notes":">"},{"actionDate":"11\/23\/2015","submission":"SUPPL-394","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125057s394lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125057Orig1s394ltr.pdf\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125057Orig1s394SumR.pdf\"}]","notes":">"},{"actionDate":"09\/09\/2015","submission":"SUPPL-393","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125057Orig1s393ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/125057Orig1s393.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"11\/06\/2014","submission":"SUPPL-390","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/29\/2014","submission":"SUPPL-384","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/07\/2014","submission":"SUPPL-381","supplementCategories":"Supplement","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2014\\\/125057Orig1s381.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/14\/2014","submission":"SUPPL-368","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125057s368lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125057Orig1s368ltr.pdf\"}]","notes":">"},{"actionDate":"09\/30\/2014","submission":"SUPPL-367","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125057s367lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125057Orig1s367ltr.pdf\"}]","notes":">"},{"actionDate":"05\/30\/2014","submission":"SUPPL-366","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125057s366lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125057Orig1s366ltr.pdf\"}]","notes":">"},{"actionDate":"09\/23\/2014","submission":"SUPPL-356","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125057s356lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125057Orig1s356ltr.pdf\"}]","notes":">"},{"actionDate":"02\/26\/2014","submission":"SUPPL-355","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125057Orig1s355lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125057Orig1s355_replace_ltr.pdf\"}]","notes":">"},{"actionDate":"09\/19\/2013","submission":"SUPPL-327","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125057s327lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125057Orig1s327ltr.pdf\"}]","notes":">"},{"actionDate":"04\/24\/2013","submission":"SUPPL-322","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125057s322lbl.pdf\"},{\"name\":\"Review 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125057s0278lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125057s0278ltr.pdf\"}]","notes":">"},{"actionDate":"12\/26\/2011","submission":"SUPPL-276","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125057s0276lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125057s276ltr.pdf\"}]","notes":">"},{"actionDate":"12\/13\/2011","submission":"SUPPL-271","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125057s271ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/07\/2011","submission":"SUPPL-255","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125057s255ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"07\/13\/2011","submission":"SUPPL-254","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125057s254ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/28\/2012","submission":"SUPPL-232","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125057s232lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125057Orig1s232ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/125057Orig1s232.pdf\"}]","notes":">"},{"actionDate":"09\/29\/2010","submission":"SUPPL-224","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/125057s224ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/25\/2011","submission":"SUPPL-215","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125057s0215lbl.pdf\"}]","notes":">"},{"actionDate":"07\/29\/2010","submission":"SUPPL-213","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/125057s0213ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2010\\\/125057Orig1s0213.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"11\/18\/2010","submission":"SUPPL-196","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125057s196lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2009\\\/125057s0196ltr.pdf\"}]","notes":">"},{"actionDate":"04\/08\/2010","submission":"SUPPL-161","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/125057s161ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/11\/2009","submission":"SUPPL-141","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/14\/2011","submission":"SUPPL-128","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125057s128ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/21\/2008","submission":"SUPPL-114","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125057s114lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/125057s114ltr.pdf\"}]","notes":">"},{"actionDate":"01\/18\/2008","submission":"SUPPL-110","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125057s0110lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/125057s0110ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2008\\\/125057s110TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2008\\\/125057s110_SumR.pdf\"}]","notes":">"},{"actionDate":"09\/05\/2007","submission":"SUPPL-108","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125057s108lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2007\\\/125057s108_ltr.pdf\"}]","notes":">"},{"actionDate":"11\/09\/2006","submission":"SUPPL-95","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"07\/30\/2007","submission":"SUPPL-94","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125057s094_LBL.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2007\\\/125057s094ltr.pdf\"}]","notes":">"},{"actionDate":"02\/27\/2007","submission":"SUPPL-89","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125057s089Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2007\\\/125057s089Ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2007\\\/125057_S0089.pdf\"}]","notes":">"},{"actionDate":"11\/09\/2006","submission":"SUPPL-71","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"06\/23\/2006","submission":"SUPPL-65","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/28\/2006","submission":"SUPPL-62","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/125057s062lbl.pdf\"}]","notes":">"},{"actionDate":"02\/16\/2007","submission":"SUPPL-60","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125057s060LBL.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2007\\\/125057s060LTR.pdf\"}]","notes":">"},{"actionDate":"10\/03\/2005","submission":"SUPPL-46","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/125057s0045,0046lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2005\\\/125057s0046ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2005\\\/125057Orig1s046.pdf\"}]","notes":">"},{"actionDate":"10\/03\/2005","submission":"SUPPL-45","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/125057s0045,0046lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2005\\\/125057s0045ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2005\\\/125057Orig1s045.pdf\"}]","notes":">"},{"actionDate":"06\/18\/2004","submission":"SUPPL-23","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/biologics\\\/2004\\\/125057_0023ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2004\\\/125057Orig1s023.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"07\/30\/2004","submission":"SUPPL-16","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/125057_0016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2004\\\/125057_0016ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2004\\\/125057Orig1s016.pdf\"}]","notes":">"},{"actionDate":"09\/12\/2003","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-11
        )

)

BLA 125057

ABBVIE INC

FDA Drug Application

Application #125057

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

ABBVIE INC