ABBVIE FDA Approval NDA 020945

Application #020945

Documents

Letter	2002-03-14
Letter	2003-09-25
Letter	2005-11-18
Letter	2008-05-20
Letter	2008-10-02
Letter	2010-01-20
Letter	2011-12-08
Letter	2012-04-02
Letter	2012-02-23
Letter	2012-11-21
Letter	2015-11-13
Label	2004-06-10
Label	2003-04-25
Label	2003-09-25
Label	2005-03-30
Label	2007-05-16
Label	2008-08-29
Label	2009-08-04
Label	2012-02-22
Label	2013-11-08
Label	2015-04-02
Label	2015-11-12
Letter	2004-06-10
Letter	2001-03-06
Letter	2005-03-30
Letter	2005-10-11
Letter	2007-05-16
Letter	2007-08-02
Letter	2008-09-03
Letter	2010-04-29
Letter	2013-11-08
Letter	2015-03-18
Letter	2015-04-01
Label	2002-03-14
Label	2005-11-17
Label	2005-10-10
Label	2007-08-02
Label	2009-12-02
Label	2010-05-07
Label	2011-12-14
Label	2012-03-29
Label	2012-11-28
Label	2015-03-17
Review	2004-03-28
Review	2007-11-19
Review	2007-11-19
Label	2016-09-16
Letter	2016-09-20
Letter	2016-11-23
Label	2016-12-02
Label	2016-12-22
Letter	2017-01-17
Label	2017-06-30
Letter	2017-06-30
Label	2018-11-23
Letter	2018-12-07
Letter	2019-08-22
Label	2019-08-22
Letter	2019-12-23
Label	2019-12-31
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
Letter	2020-10-22
Label	2020-10-23

Application Sponsors

NDA 020945

ABBVIE

Marketing Status

Discontinued

001

Application Products

001

CAPSULE;ORAL

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

NORVIR

RITONAVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1999-06-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	1999-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-12-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2000-05-08	STANDARD
LABELING; Labeling	SUPPL	5	AP	2001-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-02-05	STANDARD
LABELING; Labeling	SUPPL	7	AP	2001-03-06	STANDARD
LABELING; Labeling	SUPPL	8	AP	2002-03-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-12-24	STANDARD
LABELING; Labeling	SUPPL	13	AP	2003-09-10	STANDARD
LABELING; Labeling	SUPPL	14	AP	2005-03-28	STANDARD
LABELING; Labeling	SUPPL	16	AP	2005-11-09	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2005-10-06	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2007-05-10	STANDARD
LABELING; Labeling	SUPPL	19	AP	2008-05-16	STANDARD
LABELING; Labeling	SUPPL	20	AP	2007-07-31	STANDARD
LABELING; Labeling	SUPPL	22	AP	2008-08-29	STANDARD
LABELING; Labeling	SUPPL	23	AP	2008-10-01	STANDARD
LABELING; Labeling	SUPPL	26	AP	2009-11-23	STANDARD
LABELING; Labeling	SUPPL	28	AP	2010-04-27	901 REQUIRED
LABELING; Labeling	SUPPL	32	AP	2011-12-06	STANDARD
LABELING; Labeling	SUPPL	33	AP	2012-03-29	STANDARD
LABELING; Labeling	SUPPL	34	AP	2012-02-17	901 REQUIRED
LABELING; Labeling	SUPPL	35	AP	2012-11-19	STANDARD
LABELING; Labeling	SUPPL	36	AP	2013-11-07	STANDARD
LABELING; Labeling	SUPPL	38	AP	2015-03-16	STANDARD
LABELING; Labeling	SUPPL	39	AP	2015-03-27	901 REQUIRED
LABELING; Labeling	SUPPL	40	AP	2015-11-10	STANDARD
LABELING; Labeling	SUPPL	41	AP	2016-11-22	STANDARD
LABELING; Labeling	SUPPL	42	AP	2016-12-22	STANDARD
LABELING; Labeling	SUPPL	43	AP	2016-09-15	901 REQUIRED
LABELING; Labeling	SUPPL	44	AP	2017-06-29	STANDARD
LABELING; Labeling	SUPPL	45	AP	2018-11-15	STANDARD
LABELING; Labeling	SUPPL	46	AP	2019-08-21	STANDARD
LABELING; Labeling	SUPPL	47	AP	2019-12-19	STANDARD
LABELING; Labeling	SUPPL	48	AP	2020-10-21	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	17	Null	8
SUPPL	19	Null	4
SUPPL	26	Null	7
SUPPL	28	Null	7
SUPPL	32	Null	15
SUPPL	33	Null	6
SUPPL	34	Null	7
SUPPL	35	Null	7
SUPPL	36	Null	15
SUPPL	38	Null	7
SUPPL	39	Null	15
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

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20945
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORVIR","activeIngredients":"RITONAVIR","strength":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/21\/2020","submission":"SUPPL-48","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020945s048lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2020","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020945s048lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2019","submission":"SUPPL-47","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020945s047lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2019","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020945s047lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2019","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020945s046lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2019","submission":"SUPPL-46","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020945s046lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2018","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020945s045lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2017","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020945s044lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2017","submission":"SUPPL-44","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020945s044lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2016","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020945s042lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2016","submission":"SUPPL-42","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020945s042lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2016","submission":"SUPPL-41","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020945s041lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2016","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020945s041lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2016","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020945s043lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2015","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020945s040lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2015","submission":"SUPPL-40","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020945s040lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020945s039lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020945s039lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2015","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020945s038lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2015","submission":"SUPPL-38","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020945s038lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020945s036lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-36","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020945s036lbl.pdf\"}]","notes":""},{"actionDate":"11\/19\/2012","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020945s035lbl.pdf\"}]","notes":""},{"actionDate":"11\/19\/2012","submission":"SUPPL-35","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020945s035lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2012","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020945s033lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020945s034lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2011","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020945s032lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2011","submission":"SUPPL-32","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020945s032lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2010","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020945s028lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2009","submission":"SUPPL-26","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-23","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-22","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-20","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-18","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-16","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-17","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-14","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-13","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-8","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-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20945s5lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/20-945.pdf_Ritonovir_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NORVIR","submission":"RITONAVIR","actionType":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-10-21
        )

)

NDA 020945

ABBVIE

FDA Drug Application

Application #020945

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

ABBVIE