ABBVIE FDA Approval NDA 021251

Application #021251

Documents

Letter	2000-09-15
Letter	2003-12-08
Letter	2008-08-05
Letter	2007-11-19
Letter	2007-10-04
Letter	2009-04-10
Letter	2010-02-05
Letter	2010-05-03
Letter	2011-03-01
Letter	2011-05-10
Letter	2012-04-24
Letter	2012-05-18
Letter	2015-01-29
Letter	2015-11-17
Label	2000-09-15
Label	2002-11-27
Label	2003-12-08
Label	2005-03-30
Label	2007-04-25
Label	2007-03-07
Label	2007-07-05
Label	2007-09-26
Label	2008-06-26
Label	2009-04-16
Label	2008-10-09
Label	2009-04-23
Label	2010-02-04
Label	2012-04-24
Label	2012-02-22
Label	2012-05-17
Label	2015-04-02
Label	2015-11-12
Review	2000-09-15
Review	2007-09-26
Patient Package Insert	2000-09-15
Letter	2001-03-13
Letter	2002-01-18
Letter	2004-10-26
Letter	2005-03-30
Letter	2007-04-25
Letter	2007-01-08
Letter	2007-03-07
Letter	2007-07-05
Letter	2008-06-24
Letter	2008-10-08
Letter	2009-04-24
Letter	2010-06-16
Letter	2012-02-27
Letter	2013-01-22
Letter	2013-11-08
Letter	2015-07-06
Letter	2015-04-01
Label	2001-03-13
Label	2002-01-18
Label	2004-10-26
Label	2006-12-28
Label	2007-11-19
Label	2010-05-07
Label	2010-06-15
Label	2011-03-04
Label	2013-01-22
Label	2013-11-08
Label	2015-01-30
Label	2015-07-01
Review	2001-03-13
Review	2002-01-18
Review	2007-09-26
Label	2016-09-15
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
Pediatric Written Request	2008-03-07
Pediatric Amendment 1	2008-03-07
Pediatric Amendment 2	2008-03-07
Pediatric Amendment 3	2008-03-07
Pediatric Amendment 4	2008-03-07
Pediatric Amendment 5	2008-03-07
Pediatric Amendment 6	2008-03-07
Pediatric Clinical Pharmacology Review	2008-03-07
Pediatric Medical Review	2008-03-07
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 021251

ABBVIE

Marketing Status

Prescription

001

Application Products

001

SOLUTION;ORAL

80MG/ML;20MG/ML

KALETRA

LOPINAVIR; RITONAVIR

FDA Submissions

TYPE 3/4; Type 3 - New Dosage Form 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
EFFICACY; Efficacy	SUPPL	5	AP	2002-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-12-24	PRIORITY
LABELING; Labeling	SUPPL	9	AP	2003-12-03	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2004-10-19	UNKNOWN
LABELING; Labeling	SUPPL	11	AP	2005-03-28	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	2007-04-20	UNKNOWN
LABELING; Labeling	SUPPL	13	AP	2006-12-21	STANDARD
LABELING; Labeling	SUPPL	14	AP	2007-03-02	STANDARD
LABELING; Labeling	SUPPL	16	AP	2007-06-29	STANDARD
LABELING; Labeling	SUPPL	17	AP	2008-07-30	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	2007-11-09	PRIORITY
LABELING; Labeling	SUPPL	19	AP	2007-09-25	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	2008-06-20	PRIORITY
LABELING; Labeling	SUPPL	23	AP	2009-04-06	STANDARD
LABELING; Labeling	SUPPL	24	AP	2008-10-03	STANDARD
EFFICACY; Efficacy	SUPPL	26	AP	2009-04-20	STANDARD
LABELING; Labeling	SUPPL	29	AP	2010-01-29	STANDARD
EFFICACY; Efficacy	SUPPL	31	AP	2010-04-27	STANDARD
LABELING; Labeling	SUPPL	33	AP	2010-06-14	UNKNOWN
LABELING; Labeling	SUPPL	39	AP	2011-02-24	STANDARD
REMS; REMS	SUPPL	40	AP	2011-05-06	N/A
LABELING; Labeling	SUPPL	41	AP	2012-04-20	STANDARD
LABELING; Labeling	SUPPL	42	AP	2012-02-17	901 REQUIRED
LABELING; Labeling	SUPPL	44	AP	2012-05-16	STANDARD
LABELING; Labeling	SUPPL	45	AP	2013-01-17	STANDARD
LABELING; Labeling	SUPPL	46	AP	2013-11-07	STANDARD
EFFICACY; Efficacy	SUPPL	47	AP	2015-01-28	STANDARD
EFFICACY; Efficacy	SUPPL	49	AP	2015-06-26	STANDARD
LABELING; Labeling	SUPPL	50	AP	2015-03-27	901 REQUIRED
LABELING; Labeling	SUPPL	51	AP	2015-11-10	STANDARD
LABELING; Labeling	SUPPL	52	AP	2016-11-22	STANDARD
LABELING; Labeling	SUPPL	53	AP	2016-09-15	901 REQUIRED
LABELING; Labeling	SUPPL	54	AP	2017-06-15	STANDARD
LABELING; Labeling	SUPPL	55	AP	2017-10-13	STANDARD
LABELING; Labeling	SUPPL	56	AP	2018-11-15	STANDARD
LABELING; Labeling	SUPPL	57	AP	2019-08-21	STANDARD
LABELING; Labeling	SUPPL	58	AP	2019-12-19	STANDARD
LABELING; Labeling	SUPPL	59	AP	2020-10-21	STANDARD

Submissions Property Types

ORIG	1	Null	41
SUPPL	6	Null	0
SUPPL	22	Null	6
SUPPL	23	Null	7
SUPPL	26	Null	6
SUPPL	29	Null	6
SUPPL	31	Null	31
SUPPL	33	Null	6
SUPPL	39	Null	7
SUPPL	40	Null	6
SUPPL	41	Null	6
SUPPL	42	Null	6
SUPPL	44	Null	15
SUPPL	45	Null	6
SUPPL	46	Null	7
SUPPL	47	Null	7
SUPPL	49	Null	7
SUPPL	50	Null	7
SUPPL	51	Null	15
SUPPL	52	Null	6
SUPPL	53	Null	6
SUPPL	54	Null	7
SUPPL	55	Null	7
SUPPL	56	Null	15
SUPPL	57	Null	6
SUPPL	58	Null	6
SUPPL	59	Null	6

TE Codes

001

Prescription

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21251
            [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":"80MG\/ML;20MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/21\/2020","submission":"SUPPL-59","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-59","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-58","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-58","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021251s029,021906s022lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2009","submission":"SUPPL-26","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-23","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-23","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-24","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-22","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021251s022,021906s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2007","submission":"SUPPL-18","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-19","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-16","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-12","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-14","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-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021906s003,021251s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2005","submission":"SUPPL-11","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-10","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-9","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-5","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-4","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\\\/21251lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KALETRA","submission":"LOPINAVIR; RITONAVIR","actionType":"80MG\/ML;20MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-10-21
        )

)

NDA 021251

ABBVIE

FDA Drug Application

Application #021251

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

ABBVIE