ABBVIE FDA Approval NDA 021226

Application #021226

Documents

Letter	2000-09-15
Letter	2004-10-26
Letter	2007-07-16
Letter	2012-06-28
Letter	2013-01-22
Letter	2015-11-13
Label	2001-03-13
Label	2003-12-08
Label	2005-05-03
Label	2005-03-30
Label	2006-12-28
Label	2015-04-02
Label	2015-11-12
Review	2000-09-15
Review	2001-03-13
Review	2007-09-26
Review	2007-09-26
Patient Package Insert	2000-09-15
Letter	2001-03-13
Letter	2002-01-18
Letter	2003-12-08
Letter	2005-05-03
Letter	2005-03-30
Letter	2007-04-25
Letter	2007-01-08
Letter	2007-10-04
Letter	2010-06-09
Letter	2012-02-27
Letter	2013-11-08
Letter	2015-07-06
Letter	2015-04-01
Label	2000-09-15
Label	2002-01-18
Label	2002-11-27
Label	2004-10-26
Label	2007-04-25
Label	2007-07-10
Label	2007-09-26
Label	2010-05-07
Label	2012-02-22
Label	2012-06-28
Label	2013-01-22
Label	2013-11-08
Label	2015-07-01
Review	2002-01-18
Review	2007-09-26
Letter	2016-09-20
Label	2016-09-20
Letter	2016-11-23
Label	2016-12-02
Label	2017-06-16
Medication Guide	2017-06-16
Letter	2017-06-16
Pediatric Medical Review	1900-01-01
Pediatric Clinical Pharmacology Review	1900-01-01
Pediatric Statistical Review	1900-01-01
Label	2018-11-23
Letter	2018-12-07
Label	2019-08-22
Medication Guide	2019-08-22
Letter	2019-08-22
Letter	2019-12-23
Label	2019-12-23
Medication Guide	2019-12-23
Pediatric Amendment 1	1900-01-01
Pediatric Written Request	1900-01-01
Pediatric Amendment 2	1900-01-01
Pediatric Amendment 3	1900-01-01
Pediatric Amendment 4	1900-01-01
Pediatric Amendment 5	1900-01-01
Pediatric Amendment 6	1900-01-01
Letter	2020-10-22
Label	2020-10-23
Medication Guide	2020-10-23
Pediatric Medical Review	1900-01-01
Pediatric Clinical Pharmacology Review	1900-01-01
Pediatric Statistical Review	1900-01-01

Application Sponsors

NDA 021226

ABBVIE

Marketing Status

Discontinued

001

Application Products

001

CAPSULE;ORAL

133.3MG;33.3MG

KALETRA

LOPINAVIR; RITONAVIR

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2000-09-15	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2001-03-13	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2002-01-18	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2002-01-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-02-13	PRIORITY
EFFICACY; Efficacy	SUPPL	6	AP	2002-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-12-24	PRIORITY
LABELING; Labeling	SUPPL	12	AP	2003-12-03	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2004-10-19	UNKNOWN
EFFICACY; Efficacy	SUPPL	16	AP	2005-04-29	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2005-03-28	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	2007-04-20	UNKNOWN
LABELING; Labeling	SUPPL	19	AP	2006-12-21	STANDARD
LABELING; Labeling	SUPPL	20	AP	2007-07-09	STANDARD
LABELING; Labeling	SUPPL	22	AP	2007-09-26	STANDARD
LABELING; Labeling	SUPPL	30	AP	2010-04-27	901 REQUIRED
LABELING; Labeling	SUPPL	35	AP	2012-02-17	901 REQUIRED
LABELING; Labeling	SUPPL	36	AP	2012-06-27	STANDARD
LABELING; Labeling	SUPPL	37	AP	2013-01-17	STANDARD
LABELING; Labeling	SUPPL	38	AP	2013-11-07	STANDARD
EFFICACY; Efficacy	SUPPL	40	AP	2015-06-26	STANDARD
LABELING; Labeling	SUPPL	41	AP	2015-03-27	901 REQUIRED
LABELING; Labeling	SUPPL	42	AP	2015-11-10	STANDARD
LABELING; Labeling	SUPPL	43	AP	2016-11-22	STANDARD
LABELING; Labeling	SUPPL	44	AP	2016-09-15	901 REQUIRED
LABELING; Labeling	SUPPL	45	AP	2017-06-15	STANDARD
LABELING; Labeling	SUPPL	46	AP	2018-11-15	STANDARD
LABELING; Labeling	SUPPL	47	AP	2019-08-21	STANDARD
LABELING; Labeling	SUPPL	48	AP	2019-12-19	STANDARD
LABELING; Labeling	SUPPL	49	AP	2020-10-21	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	30	Null	6
SUPPL	35	Null	7
SUPPL	36	Null	15
SUPPL	37	Null	6
SUPPL	38	Null	6
SUPPL	40	Null	6
SUPPL	41	Null	6
SUPPL	42	Null	7
SUPPL	43	Null	7
SUPPL	44	Null	15
SUPPL	45	Null	6
SUPPL	46	Null	6
SUPPL	47	Null	7
SUPPL	48	Null	7
SUPPL	49	Null	15

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21226
            [companyName] => ABBVIE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/021226s049lbl.pdf#page=53"]
            [products] => [{"drugName":"KALETRA","activeIngredients":"LOPINAVIR; RITONAVIR","strength":"133.3MG;33.3MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/21\/2020","submission":"SUPPL-49","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021226s049lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2020","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021226s049lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2019","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021226s048lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2019","submission":"SUPPL-48","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021226s048lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2019","submission":"SUPPL-47","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021226s047lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2019","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021226s047lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2018","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021226s046lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2017","submission":"SUPPL-45","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021226s045lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2017","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021226s045lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2016","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021226s043lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2016","submission":"SUPPL-43","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021226s043lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2016","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021226s044lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2016","submission":"SUPPL-44","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021226s044lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2015","submission":"SUPPL-42","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021226s042lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2015","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021226s042lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2015","submission":"SUPPL-40","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021226s040lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2015","submission":"SUPPL-40","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021226s040lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2015","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021226s040lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2015","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021226s040lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021226s041lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021226s041lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-38","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021226s038lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021226s038lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2013","submission":"SUPPL-37","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021226s037lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2013","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021226s037lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2012","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021226s036lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2012","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021226s036lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-35","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021226s035lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2010","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021226s030lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2007","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021226s022lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2007","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021226s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2007","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021226s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2006","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021226s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2005","submission":"SUPPL-16","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021226s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2005","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021226s017,021251s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2004","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21226s014,21251s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2003","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21226slr012,21251slr009_kaletra_lbl.pdf\"}]","notes":""},{"actionDate":"11\/27\/2002","submission":"SUPPL-6","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21226se7-006,21251se7-005_Kaletra_lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2002","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21226s3lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2001","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/21-251S002_Kaletra_prntlbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21226lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KALETRA","submission":"LOPINAVIR; RITONAVIR","actionType":"133.3MG;33.3MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2020-10-21
        )

)

NDA 021226

ABBVIE

FDA Drug Application

Application #021226

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

ABBVIE