ABBVIE FDA Approval NDA 021906

Application #021906

Documents

Letter	2005-11-01
Letter	2007-07-05
Letter	2009-04-10
Letter	2009-04-24
Letter	2010-02-05
Letter	2010-05-03
Letter	2011-03-01
Letter	2011-05-10
Letter	2012-04-24
Letter	2015-01-29
Letter	2015-11-17
Label	2007-04-25
Label	2007-03-07
Label	2007-11-19
Label	2009-04-16
Label	2009-04-23
Label	2010-02-04
Label	2012-04-24
Label	2012-02-22
Label	2015-04-02
Label	2015-11-12
Letter	2007-04-25
Letter	2007-01-08
Letter	2007-03-07
Letter	2007-11-19
Letter	2007-10-04
Letter	2008-06-24
Letter	2008-10-08
Letter	2010-06-16
Letter	2012-02-27
Letter	2012-05-18
Letter	2013-01-22
Letter	2013-11-08
Letter	2015-07-06
Letter	2015-04-01
Label	2005-11-01
Label	2006-12-28
Label	2007-07-05
Label	2007-09-26
Label	2008-06-26
Label	2008-10-09
Label	2010-05-07
Label	2010-06-15
Label	2011-03-04
Label	2012-05-17
Label	2013-01-22
Label	2013-11-08
Label	2015-01-30
Label	2015-07-01
Review	2007-07-18
Label	2016-09-16
Letter	2016-09-20
Letter	2016-11-23
Label	2016-11-29
Label	2017-06-16
Letter	2017-06-16
Label	2017-10-18
Medication Guide	2017-10-18
Letter	2017-10-18
Label	2018-11-23
Letter	2018-12-07
Letter	2019-08-22
Label	2019-08-22
Letter	2019-12-23
Label	2019-12-23
Medication Guide	2019-12-23
Letter	2020-10-23
Label	2020-10-23
Medication Guide	2020-10-23

Application Sponsors

NDA 021906

ABBVIE

Marketing Status

Prescription	001
Prescription	002

Application Products

001	TABLET;ORAL	200MG;50MG	1	KALETRA	LOPINAVIR; RITONAVIR
002	TABLET;ORAL	100MG;25MG	1	KALETRA	LOPINAVIR; RITONAVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2005-10-28	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2007-04-20	UNKNOWN
LABELING; Labeling	SUPPL	3	AP	2006-12-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2007-03-02	STANDARD
LABELING; Labeling	SUPPL	5	AP	2007-06-29	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2007-11-09	PRIORITY
LABELING; Labeling	SUPPL	8	AP	2007-09-25	STANDARD
LABELING; Labeling	SUPPL	13	AP	2008-06-20	STANDARD
LABELING; Labeling	SUPPL	14	AP	2009-04-06	STANDARD
LABELING; Labeling	SUPPL	15	AP	2008-10-03	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2009-04-20	STANDARD
LABELING; Labeling	SUPPL	22	AP	2010-01-29	STANDARD
EFFICACY; Efficacy	SUPPL	24	AP	2010-04-27	STANDARD
LABELING; Labeling	SUPPL	26	AP	2010-06-14	UNKNOWN
LABELING; Labeling	SUPPL	32	AP	2011-02-24	STANDARD
REMS; REMS	SUPPL	33	AP	2011-05-06	N/A
LABELING; Labeling	SUPPL	34	AP	2012-04-20	STANDARD
LABELING; Labeling	SUPPL	35	AP	2012-02-17	901 REQUIRED
LABELING; Labeling	SUPPL	36	AP	2012-05-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2012-11-30	PRIORITY
LABELING; Labeling	SUPPL	38	AP	2013-01-17	STANDARD
LABELING; Labeling	SUPPL	39	AP	2013-11-07	STANDARD
EFFICACY; Efficacy	SUPPL	40	AP	2015-01-28	STANDARD
EFFICACY; Efficacy	SUPPL	42	AP	2015-06-26	STANDARD
LABELING; Labeling	SUPPL	43	AP	2015-03-27	901 REQUIRED
LABELING; Labeling	SUPPL	44	AP	2015-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2015-12-02	PRIORITY
LABELING; Labeling	SUPPL	46	AP	2016-11-22	STANDARD
LABELING; Labeling	SUPPL	47	AP	2016-09-15	STANDARD
LABELING; Labeling	SUPPL	49	AP	2017-06-15	STANDARD
LABELING; Labeling	SUPPL	50	AP	2017-10-13	STANDARD
LABELING; Labeling	SUPPL	51	AP	2018-11-15	STANDARD
LABELING; Labeling	SUPPL	52	AP	2019-08-21	STANDARD
LABELING; Labeling	SUPPL	53	AP	2019-12-19	STANDARD
LABELING; Labeling	SUPPL	54	AP	2020-10-21	STANDARD

Submissions Property Types

SUPPL	14	Null	7
SUPPL	17	Null	6
SUPPL	22	Null	7
SUPPL	24	Null	7
SUPPL	26	Null	7
SUPPL	32	Null	7
SUPPL	33	Null	7
SUPPL	34	Null	15
SUPPL	35	Null	6
SUPPL	36	Null	6
SUPPL	37	Null	0
SUPPL	38	Null	15
SUPPL	39	Null	6
SUPPL	40	Null	7
SUPPL	42	Null	7
SUPPL	43	Null	7
SUPPL	44	Null	7
SUPPL	45	Null	0
SUPPL	46	Null	15
SUPPL	47	Null	6
SUPPL	49	Null	6
SUPPL	50	Null	6
SUPPL	51	Null	7
SUPPL	52	Null	7
SUPPL	53	Null	15
SUPPL	54	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21906
            [companyName] => ABBVIE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/021251s059,021906s054lbl.pdf#page=53"]
            [products] => [{"drugName":"KALETRA","activeIngredients":"LOPINAVIR; RITONAVIR","strength":"200MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"KALETRA","activeIngredients":"LOPINAVIR; RITONAVIR","strength":"100MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/21\/2020","submission":"SUPPL-54","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021251s059,021906s054lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2020","submission":"SUPPL-54","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021251s059,021906s054lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2019","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021251s058,021906s053lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2019","submission":"SUPPL-53","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021251s058,021906s053lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2019","submission":"SUPPL-52","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021251s057,021906s052lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2019","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021251s057,021906s052lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2018","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021906s051lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2017","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021251s055,021906s050lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2017","submission":"SUPPL-50","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021251s055,021906s050lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2017","submission":"SUPPL-49","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021251s054,021906s049lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2017","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021251s054,021906s049lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2016","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021251s052_021906s046lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2016","submission":"SUPPL-46","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021251s052_021906s046lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2016","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021251s053,021906s047lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2015","submission":"SUPPL-44","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021251s051,021906s044lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2015","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021251s051,021906s044lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2015","submission":"SUPPL-42","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021906s042,021251s049lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2015","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021906s042,021251s049lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2015","submission":"SUPPL-42","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021906s042,021251s049lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2015","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021906s042,021251s049lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021251s050,021906s043lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021251s050,021906s043lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2015","submission":"SUPPL-40","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021251s047,021906s040lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-39","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021251s046_021906s039lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021251s046_021906s039lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2013","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021251s045,021906s038lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2013","submission":"SUPPL-38","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021251s045,021906s038lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2012","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021906s036,021251s044lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2012","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021251s041,021906s034lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021251s042,021906s035lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021251s042,021906s035lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2011","submission":"SUPPL-32","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021251s039,021906s032lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2010","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021906s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2010","submission":"SUPPL-24","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021906s024,021251s031lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2010","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021251s029,021906s022lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2009","submission":"SUPPL-17","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021251s026,021906s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2009","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021251s023,021906s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2009","submission":"SUPPL-14","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021251s023,021906s014lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2008","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021906s015,021251s024lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2008","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021251s022,021906s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2007","submission":"SUPPL-7","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021251s018,021906s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2007","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021906s008,021251s019lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2007","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021251s016,021906s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2007","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021251s012,021906s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/02\/2007","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021251s014,021906s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2006","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021906s003,021251s013lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021906lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KALETRA","submission":"LOPINAVIR; RITONAVIR","actionType":"200MG;50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KALETRA","submission":"LOPINAVIR; RITONAVIR","actionType":"100MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-10-21
        )

)

NDA 021906

ABBVIE

FDA Drug Application

Application #021906

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

ABBVIE