ABBVIE INC FDA Approval NDA 207931

NDA 207931

ABBVIE INC

FDA Drug Application

Application #207931

Documents

Letter2015-07-24
Letter2015-10-26
Letter2016-06-23
Letter2016-01-29
Label2015-07-24
Label2015-10-23
Label2016-02-01
Label2016-06-23
Review2016-05-25
Label2017-02-15
Letter2017-02-15
Label2017-02-28
Letter2017-03-03
Label2017-03-23
Label2017-03-23
Letter2017-03-24
Letter2017-03-24
Label2017-11-13
Letter2018-07-25
Label2018-08-29
Medication Guide2018-08-29
Label2019-12-09
Medication Guide2019-12-09
Letter2019-12-10

Application Sponsors

NDA 207931ABBVIE INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL12.5MG;75MG;50MG1TECHNIVIEOMBITASVIR; PARITAPREVIR; RITONAVIR

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2015-07-24PRIORITY
LABELING; LabelingSUPPL2AP2016-01-28STANDARD
LABELING; LabelingSUPPL4AP2016-06-22STANDARD
EFFICACY; EfficacySUPPL6AP2017-02-24STANDARD
LABELING; LabelingSUPPL7AP2017-03-22STANDARD
LABELING; LabelingSUPPL8AP2017-02-14STANDARD
LABELING; LabelingSUPPL9AP2017-03-22STANDARD
LABELING; LabelingSUPPL11AP2017-11-09STANDARD
LABELING; LabelingSUPPL12AP2018-07-23STANDARD
LABELING; LabelingSUPPL13AP2019-12-06STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL4Null7
SUPPL6Null7
SUPPL7Null7
SUPPL8Null31
SUPPL9Null15
SUPPL11Null15
SUPPL12Null15
SUPPL13Null6

CDER Filings

ABBVIE INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207931
            [companyName] => ABBVIE INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/207931s013lbl.pdf#page=39"]
            [products] => [{"drugName":"TECHNIVIE","activeIngredients":"OMBITASVIR; PARITAPREVIR; RITONAVIR","strength":"12.5MG;75MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/06\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207931s013lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2018","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207931s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207931s011lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207931s007s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207931s007s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207931s007s009lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2017","submission":"SUPPL-6","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207931s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207931s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207931Orig1s004lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207931s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207931s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207931Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/24\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207931Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207931Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207931Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/06\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207931s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207931Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"07\/23\/2018","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207931s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207931Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"11\/09\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207931s011lbl.pdf\"}]","notes":">"},{"actionDate":"03\/22\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207931s007s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207931Orig1s007,207931Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"02\/14\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207931s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207931Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"03\/22\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207931s007s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207931Orig1s007,207931Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"02\/24\/2017","submission":"SUPPL-6","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207931s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207931Orig1s006Replacementltr.pdf\"}]","notes":">"},{"actionDate":"06\/22\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207931Orig1s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207931Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"01\/28\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207931s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207931Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"10\/22\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207931s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207931Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-12-06
        )

)
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