VIIV HLTHCARE FDA Approval NDA 205551

NDA 205551

VIIV HLTHCARE

FDA Drug Application

Application #205551

Documents

Letter2015-08-10
Letter2015-09-30
Letter2016-04-22
Label2014-08-26
Label2015-08-07
Letter2014-08-27
Label2015-10-07
Label2016-04-27
Review2015-08-11
Label2017-03-28
Letter2017-03-29
Label2017-11-24
Letter2017-11-27
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Label2018-05-14
Letter2018-05-16
Label2018-09-10
Label2018-09-10
Letter2018-09-12
Letter2018-09-12
Label2019-05-07
Letter2019-05-08
Letter2019-10-25
Label2019-10-28
Medication Guide2019-10-28
Letter2020-03-25
Label2020-03-25
Letter2021-03-02
Label2021-03-02
Medication Guide2021-03-02
Letter2021-03-24
Label2021-03-25
Medication Guide2021-03-25
Letter2022-03-31
Label2022-03-31
Medication Guide2022-03-31
Label2022-10-11
Medication Guide2022-10-11
Letter2022-10-11

Application Sponsors

NDA 205551VIIV HLTHCARE

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 600MG BASE;EQ 50MG BASE;300MG1TRIUMEQABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2014-08-22STANDARD
LABELING; LabelingSUPPL2AP2015-08-05STANDARD
LABELING; LabelingSUPPL4AP2015-09-28STANDARD
EFFICACY; EfficacySUPPL5AP2016-04-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2016-04-01STANDARD
LABELING; LabelingSUPPL10AP2017-03-27STANDARD
EFFICACY; EfficacySUPPL11AP2017-11-21PRIORITY
LABELING; LabelingSUPPL13AP2018-05-11STANDARD
LABELING; LabelingSUPPL14AP2018-09-06STANDARD
LABELING; LabelingSUPPL15AP2018-09-06STANDARD
LABELING; LabelingSUPPL16AP2019-05-03STANDARD
LABELING; LabelingSUPPL21AP2020-03-24STANDARD
LABELING; LabelingSUPPL22AP2019-10-24STANDARD
EFFICACY; EfficacySUPPL25AP2021-03-01STANDARD
LABELING; LabelingSUPPL26AP2021-03-23STANDARD
EFFICACY; EfficacySUPPL28AP2022-03-30PRIORITY
LABELING; LabelingSUPPL29AP2022-10-07STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL4Null15
SUPPL5Null6
SUPPL6Null0
SUPPL10Null15
SUPPL11Null15
SUPPL13Null6
SUPPL14Null15
SUPPL15Null6
SUPPL16Null7
SUPPL21Null7
SUPPL22Null7
SUPPL25Null6
SUPPL26Null7
SUPPL28Null7
SUPPL29Null7

CDER Filings

VIIV HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205551
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/205551s022lbl.pdf#page=44"]
            [products] => [{"drugName":"TRIUMEQ","activeIngredients":"ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE","strength":"EQ 600MG BASE;EQ 50MG BASE;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/24\/2020","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205551s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2020","submission":"SUPPL-21","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205551s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2019","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205551s022lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2019","submission":"SUPPL-22","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205551s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205551s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205551s016lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205551s014s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205551s014s015lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205551s013lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205551s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2017","submission":"SUPPL-11","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205551s011lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205551s010lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2016","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205551s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205551s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205551s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205551s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205551s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205551s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205551s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/22\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205551s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205551Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205551Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/24\/2019","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205551s022lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205551Orig1s022ltr.pdf\"}]","notes":">"},{"actionDate":"03\/24\/2020","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205551s021lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205551Orig1s021ltr.pdf\"}]","notes":">"},{"actionDate":"05\/03\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205551s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205551Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"09\/06\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205551s014s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205551Orig1s014s015REPLACEMENTLtr.pdf\"}]","notes":">"},{"actionDate":"09\/06\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205551s014s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205551Orig1s014s015REPLACEMENTLtr.pdf\"}]","notes":">"},{"actionDate":"05\/11\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205551s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205551Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"11\/21\/2017","submission":"SUPPL-11","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205551s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205551Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"03\/27\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205551s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205551Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"04\/01\/2016","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/21\/2016","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205551s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205551Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"09\/28\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205551s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205551Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"08\/05\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205551s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205551Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"06\/15\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-24
        )

)
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