ABBVIE INC FDA Approval NDA 206619

Application #206619

Documents

Letter	2015-07-22
Letter	2015-10-26
Letter	2016-04-26
Letter	2016-01-29
Letter	2016-06-23
Label	2015-07-22
Label	2015-10-15
Review	2015-01-23
Letter	2014-12-23
Letter	2015-03-26
Letter	2015-10-14
Label	2014-12-23
Label	2015-03-26
Label	2015-10-23
Label	2016-04-27
Label	2016-02-01
Label	2016-06-23
Summary Review	2015-01-23
Label	2017-02-15
Letter	2017-02-15
Label	2017-03-23
Label	2017-03-23
Letter	2017-03-24
Letter	2017-03-24
Letter	2017-11-13
Label	2017-11-13
Letter	2018-07-25
Label	2018-08-29
Medication Guide	2018-08-29
Label	2019-12-09
Medication Guide	2019-12-09
Letter	2019-12-10

Application Sponsors

NDA 206619

ABBVIE INC

Marketing Status

Prescription

001

Application Products

001

TABLET, TABLET;ORAL

250.0MG;12.5MG;75.0MG;EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG

VIEKIRA PAK (COPACKAGED)

DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2014-12-19	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2015-07-09	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2015-03-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2015-07-30	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2015-07-20	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-10-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2015-09-22	PRIORITY
LABELING; Labeling	SUPPL	8	AP	2015-10-22	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2016-04-22	PRIORITY
LABELING; Labeling	SUPPL	10	AP	2016-01-28	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-06-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2016-08-17	UNKNOWN
LABELING; Labeling	SUPPL	13	AP	2017-03-22	STANDARD
LABELING; Labeling	SUPPL	14	AP	2017-02-14	STANDARD
LABELING; Labeling	SUPPL	15	AP	2017-03-22	STANDARD
LABELING; Labeling	SUPPL	17	AP	2017-11-09	STANDARD
LABELING; Labeling	SUPPL	18	AP	2018-07-23	STANDARD
LABELING; Labeling	SUPPL	20	AP	2019-12-06	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	0
SUPPL	3	Null	15
SUPPL	4	Null	0
SUPPL	5	Null	15
SUPPL	6	Null	6
SUPPL	7	Null	0
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	6
SUPPL	11	Null	6
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	17	Null	7
SUPPL	18	Null	31
SUPPL	20	Null	7

CDER Filings

ABBVIE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206619
            [companyName] => ABBVIE INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/206619s020lbl.pdf#page=49"]
            [products] => [{"drugName":"VIEKIRA PAK (COPACKAGED)","activeIngredients":"DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR","strength":"250.0MG;12.5MG;75.0MG;EQ 250MG BASE,N\/A,N\/A,N\/A; N\/A,12.5MG,75MG,50MG","dosageForm":"TABLET, TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/06\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206619s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206619s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206619s017lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206619s013s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206619s013s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206619s013s015lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2017","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206619s014lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206619Orig1s011lbl.pdf\"}]","notes":""},{"actionDate":"04\/22\/2016","submission":"SUPPL-9","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206619s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206619s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206619s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206619s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206619s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206619s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206619s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206619lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/19\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206619lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/206619Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206619Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206619Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/06\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206619s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206619Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"07\/23\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206619s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206619Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"11\/09\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206619s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206619Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"03\/22\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206619s013s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206619Orig1s013,206619Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"02\/14\/2017","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206619s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206619Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"03\/22\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206619s013s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206619Orig1s013,206619Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"08\/17\/2016","submission":"SUPPL-12","supplementCategories":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/21\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206619Orig1s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206619Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"01\/28\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206619s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206619Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"04\/22\/2016","submission":"SUPPL-9","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206619s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206619Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"10\/22\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206619s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206619Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"09\/22\/2015","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/13\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206619s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206619Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"07\/20\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206619s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206619Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"07\/30\/2015","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/25\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206619s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206619Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"07\/09\/2015","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/19\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-06
        )

)

NDA 206619

ABBVIE INC

FDA Drug Application

Application #206619

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

ABBVIE INC