ABBVIE FDA Approval NDA 022417

Application #022417

Documents

Letter	2010-02-17
Letter	2011-12-08
Letter	2012-02-27
Letter	2012-11-23
Letter	2013-11-08
Letter	2015-03-17
Letter	2015-04-03
Label	2010-05-07
Label	2011-12-14
Label	2013-11-08
Label	2015-04-07
Label	2015-11-12
Summary Review	2010-06-06
Letter	2010-05-03
Letter	2015-11-17
Label	2010-02-16
Label	2012-02-22
Label	2012-11-28
Label	2015-03-19
Review	2010-06-06
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
Label	2018-11-23
Letter	2018-12-07
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 022417

ABBVIE

Marketing Status

Prescription

001

Application Products

001

TABLET;ORAL

100MG

NORVIR

RITONAVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2010-02-10	STANDARD
LABELING; Labeling	SUPPL	6	AP	2011-12-06	STANDARD
LABELING; Labeling	SUPPL	7	AP	2012-02-17	901 REQUIRED
LABELING; Labeling	SUPPL	8	AP	2012-11-20	STANDARD
LABELING; Labeling	SUPPL	10	AP	2013-11-07	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-03-16	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-03-27	901 REQUIRED
LABELING; Labeling	SUPPL	14	AP	2015-11-10	STANDARD
LABELING; Labeling	SUPPL	15	AP	2016-11-22	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-12-22	STANDARD
LABELING; Labeling	SUPPL	17	AP	2016-09-15	901 REQUIRED
LABELING; Labeling	SUPPL	18	AP	2017-06-29	STANDARD
LABELING; Labeling	SUPPL	19	AP	2017-06-07	STANDARD
LABELING; Labeling	SUPPL	20	AP	2017-09-29	STANDARD
LABELING; Labeling	SUPPL	21	AP	2018-11-15	STANDARD
LABELING; Labeling	SUPPL	22	AP	2019-08-21	STANDARD
LABELING; Labeling	SUPPL	23	AP	2019-12-19	STANDARD
LABELING; Labeling	SUPPL	24	AP	2020-10-21	STANDARD
LABELING; Labeling	SUPPL	25	AP	2022-06-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	10	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	15
SUPPL	14	Null	6
SUPPL	15	Null	15
SUPPL	16	Null	6
SUPPL	17	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	21	Null	6
SUPPL	22	Null	7
SUPPL	23	Null	7
SUPPL	24	Null	15

TE Codes

001

Prescription

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22417
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORVIR","activeIngredients":"RITONAVIR","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/21\/2020","submission":"SUPPL-24","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-24","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-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"12\/19\/2019","submission":"SUPPL-23","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"08\/21\/2019","submission":"SUPPL-22","supplementCategories":"Labeling-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-22","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":"11\/15\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022417s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2017","submission":"SUPPL-20","supplementCategories":"Labeling-Package 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020659s064,022417s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Patient 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-15","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-15","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020659s060,022417s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020659s058_022417s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-10","supplementCategories":"Labeling-Patient 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-8","supplementCategories":"Labeling-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-8","supplementCategories":"Labeling-Patient 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-7","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-6","supplementCategories":"Labeling-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-6","supplementCategories":"Labeling-Patient 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-1","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":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022417lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NORVIR","submission":"RITONAVIR","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-10-21
        )

)

NDA 022417

ABBVIE

FDA Drug Application

Application #022417

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

ABBVIE