VIIV HLTHCARE FDA Approval NDA 210192

NDA 210192

VIIV HLTHCARE

FDA Drug Application

Application #210192

Documents

Label2017-11-24
Letter2017-11-27
Label2018-01-18
Letter2018-01-26
Review2018-07-02
Label2018-09-11
Label2018-09-11
Letter2018-09-12
Letter2018-09-12
Letter2019-10-25
Label2019-10-25
Label2020-07-15
Letter2020-07-20
Letter2021-03-24
Label2021-03-25
Label2021-07-12
Letter2021-07-13
Letter2022-10-11
Label2022-10-11

Application Sponsors

NDA 210192VIIV HLTHCARE

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 50MG BASE;EQ 25MG BASE1JULUCADOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2017-11-21PRIORITY
LABELING; LabelingSUPPL2AP2018-09-06STANDARD
LABELING; LabelingSUPPL4AP2018-09-06STANDARD
EFFICACY; EfficacySUPPL7AP2020-07-14STANDARD
LABELING; LabelingSUPPL8AP2019-10-24STANDARD
EFFICACY; EfficacySUPPL11AP2021-07-09STANDARD
LABELING; LabelingSUPPL12AP2021-03-23STANDARD
LABELING; LabelingSUPPL13AP2022-10-07STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null31
SUPPL4Null7
SUPPL7Null6
SUPPL8Null15
SUPPL11Null15
SUPPL12Null7
SUPPL13Null6

CDER Filings

VIIV HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210192
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"JULUCA","activeIngredients":"DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE","strength":"EQ 50MG BASE;EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/14\/2020","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210192s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210192s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210192s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210192s002s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210192s002s004lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210192s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210192s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/210192s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/210192s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/210192Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/210192Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/24\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210192s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210192Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"07\/14\/2020","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210192s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210192Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"09\/06\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210192s002s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210192Orig1s002s004Ltr.pdf\"}]","notes":">"},{"actionDate":"09\/06\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210192s002s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210192Orig1s002s004Ltr.pdf\"}]","notes":">"},{"actionDate":"01\/17\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210192s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210192Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-07-14
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.