Documents
Application Sponsors
Marketing Status
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 | 1 | 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
)
)