ABBVIE FDA Approval NDA 020659

Application #020659

Documents

Letter	2001-03-06
Letter	2002-03-14
Letter	2003-09-25
Letter	2005-03-30
Letter	2005-11-18
Letter	2007-05-16
Letter	2008-05-20
Letter	2011-12-08
Letter	2012-02-27
Letter	2012-11-23
Letter	2015-03-17
Letter	2015-04-03
Label	2003-04-25
Label	2003-09-25
Label	2005-10-10
Label	2008-08-29
Label	2010-02-16
Label	2010-05-07
Label	2011-12-14
Label	2013-11-08
Label	2015-03-19
Letter	2005-10-11
Letter	2007-08-02
Letter	2008-09-03
Letter	2008-10-02
Letter	2010-02-17
Letter	2010-01-20
Letter	2010-05-03
Letter	2013-11-08
Letter	2015-11-17
Label	2002-03-14
Label	2005-03-30
Label	2005-11-17
Label	2007-05-16
Label	2007-08-02
Label	2009-08-04
Label	2009-12-02
Label	2012-02-22
Label	2012-11-28
Label	2015-04-07
Label	2015-11-12
Review	2005-04-27
Review	2007-11-19
Review	2007-11-19
Letter	2016-09-19
Label	2016-09-15
Letter	2016-11-23
Label	2016-12-01
Label	2016-12-22
Letter	2016-12-23
Label	2017-06-08
Letter	2017-06-08
Label	2017-06-30
Letter	2017-06-30
Label	2017-10-03
Letter	2017-10-03
Pediatric Medical Review	1900-01-01
Pediatric Clinical Pharmacology Review	1900-01-01
Pediatric Written Request	1900-01-01
Pediatric Amendment 1	1900-01-01
Label	2018-11-23
Letter	2018-12-07
Review	1997-04-09
Letter	2019-08-22
Label	2019-08-22
Letter	2019-12-23
Label	2019-12-31
Letter	2020-10-22
Label	2020-10-23
Letter	2022-12-16
Label	2022-12-20

Application Sponsors

NDA 020659

ABBVIE

Marketing Status

Prescription

001

Application Products

001

SOLUTION;ORAL

80MG/ML

NORVIR

RITONAVIR

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-03-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-10-01	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1996-09-24	STANDARD
LABELING; Labeling	SUPPL	5	AP	1997-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-09-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-05-09	PRIORITY
EFFICACY; Efficacy	SUPPL	8	AP	1997-03-14	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1997-10-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-01-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-05-01	PRIORITY
LABELING; Labeling	SUPPL	12	AP	1998-02-12	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	1999-05-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-07-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-09-25	PRIORITY
LABELING; Labeling	SUPPL	16	AP	1998-10-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1999-02-26	PRIORITY
LABELING; Labeling	SUPPL	18	AP	1999-04-12	STANDARD
LABELING; Labeling	SUPPL	19	AP	1999-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1999-10-28	PRIORITY
LABELING; Labeling	SUPPL	21	AP	1999-10-21	STANDARD
LABELING; Labeling	SUPPL	22	AP	1999-10-26	STANDARD
LABELING; Labeling	SUPPL	23	AP	2000-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2000-09-01	PRIORITY
LABELING; Labeling	SUPPL	25	AP	2001-08-21	STANDARD
LABELING; Labeling	SUPPL	26	AP	2001-03-06	STANDARD
LABELING; Labeling	SUPPL	27	AP	2002-03-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2002-12-24	PRIORITY
LABELING; Labeling	SUPPL	30	AP	2003-09-10	STANDARD
LABELING; Labeling	SUPPL	32	AP	2005-03-28	STANDARD
LABELING; Labeling	SUPPL	33	AP	2005-11-09	STANDARD
EFFICACY; Efficacy	SUPPL	34	AP	2005-10-06	PRIORITY
LABELING; Labeling	SUPPL	36	AP	2007-05-10	STANDARD
LABELING; Labeling	SUPPL	39	AP	2008-05-16	STANDARD
LABELING; Labeling	SUPPL	40	AP	2007-07-31	STANDARD
LABELING; Labeling	SUPPL	42	AP	2008-08-29	STANDARD
LABELING; Labeling	SUPPL	43	AP	2008-10-01	STANDARD
LABELING; Labeling	SUPPL	45	AP	2010-02-10	STANDARD
LABELING; Labeling	SUPPL	47	AP	2009-11-23	STANDARD
LABELING; Labeling	SUPPL	50	AP	2010-04-27	901 REQUIRED
LABELING; Labeling	SUPPL	55	AP	2011-12-06	STANDARD
LABELING; Labeling	SUPPL	56	AP	2012-02-17	901 REQUIRED
LABELING; Labeling	SUPPL	57	AP	2012-11-20	STANDARD
LABELING; Labeling	SUPPL	58	AP	2013-11-07	STANDARD
LABELING; Labeling	SUPPL	60	AP	2015-03-16	STANDARD
LABELING; Labeling	SUPPL	61	AP	2015-03-27	901 REQUIRED
LABELING; Labeling	SUPPL	62	AP	2015-11-10	STANDARD
LABELING; Labeling	SUPPL	63	AP	2016-11-22	STANDARD
LABELING; Labeling	SUPPL	64	AP	2016-12-22	STANDARD
LABELING; Labeling	SUPPL	65	AP	2016-09-15	901 REQUIRED
LABELING; Labeling	SUPPL	66	AP	2017-06-29	STANDARD
LABELING; Labeling	SUPPL	67	AP	2017-06-07	STANDARD
LABELING; Labeling	SUPPL	68	AP	2017-09-29	STANDARD
LABELING; Labeling	SUPPL	69	AP	2018-11-15	STANDARD
LABELING; Labeling	SUPPL	70	AP	2019-08-21	STANDARD
LABELING; Labeling	SUPPL	71	AP	2019-12-19	STANDARD
LABELING; Labeling	SUPPL	72	AP	2020-10-21	STANDARD
LABELING; Labeling	SUPPL	73	AP	2022-06-15	STANDARD

Submissions Property Types

ORIG	1	Null	11
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	41
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	24	Null	0
SUPPL	28	Null	0
SUPPL	34	Null	26
SUPPL	39	Null	4
SUPPL	45	Null	7
SUPPL	47	Null	7
SUPPL	50	Null	6
SUPPL	55	Null	15
SUPPL	56	Null	15
SUPPL	57	Null	6
SUPPL	58	Null	7
SUPPL	60	Null	7
SUPPL	61	Null	7
SUPPL	62	Null	7
SUPPL	63	Null	15
SUPPL	64	Null	6
SUPPL	65	Null	6
SUPPL	66	Null	7
SUPPL	67	Null	7
SUPPL	68	Null	15
SUPPL	69	Null	6
SUPPL	70	Null	6
SUPPL	71	Null	6
SUPPL	72	Null	7

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20659
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORVIR","activeIngredients":"RITONAVIR","strength":"80MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/21\/2020","submission":"SUPPL-72","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020659s072,022417s024,209512s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2020","submission":"SUPPL-72","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020659s072,022417s024,209512s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2019","submission":"SUPPL-71","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"12\/19\/2019","submission":"SUPPL-71","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"08\/21\/2019","submission":"SUPPL-70","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020659s070,022417s022,209512s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2019","submission":"SUPPL-70","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020659s070,022417s022,209512s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2018","submission":"SUPPL-69","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020659s069lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2017","submission":"SUPPL-68","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209512s002,022417s020,020659s068lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2017","submission":"SUPPL-68","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209512s002,022417s020,020659s068lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2017","submission":"SUPPL-66","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020659s066,022417s018,209512s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2017","submission":"SUPPL-66","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020659s066,022417s018,209512s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2017","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022417s19_020659s67lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2016","submission":"SUPPL-64","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020659s064,022417s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2016","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020659s064,022417s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2016","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020659S063_022417S15lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2016","submission":"SUPPL-63","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020659S063_022417S15lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2016","submission":"SUPPL-65","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020659s065,022417s017lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2015","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020659s062,022417s014lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2015","submission":"SUPPL-62","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020659s062,022417s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022417s013,020659s061lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022417s013,020659s061lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2015","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020659s060,022417s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2015","submission":"SUPPL-60","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020659s060,022417s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020659s058_022417s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2012","submission":"SUPPL-57","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022417s008,020659s057lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2012","submission":"SUPPL-57","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022417s008,020659s057lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-56","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020659s056,022417s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2011","submission":"SUPPL-55","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020659s055,022417s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2011","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020659s055,022417s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2010","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020659s050,022417s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/10\/2010","submission":"SUPPL-45","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020659s045lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2009","submission":"SUPPL-47","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020945s026,020659s047lbl.pdf\"}]","notes":""},{"actionDate":"10\/01\/2008","submission":"SUPPL-43","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020659s043,020945s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2008","submission":"SUPPL-42","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020945s022,020659s042lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2007","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020659s040,020945s020lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2007","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020659s036,020945s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2005","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020945s016,020659s033lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2005","submission":"SUPPL-34","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020659s034,020945s017lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2005","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/20659s032,20945s014lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2003","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20659slr030,20945slr013_norvir_lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2002","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20659S27lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2001","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20945s5lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NORVIR","submission":"RITONAVIR","actionType":"80MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-10-21
        )

)

NDA 020659

ABBVIE

FDA Drug Application

Application #020659

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

ABBVIE