Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | EQ 50MG BASE | 1 | TIVICAY | DOLUTEGRAVIR SODIUM |
| 002 | TABLET;ORAL | EQ 10MG BASE | 1 | TIVICAY | DOLUTEGRAVIR SODIUM |
| 003 | TABLET;ORAL | EQ 25MG BASE | 1 | TIVICAY | DOLUTEGRAVIR SODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2013-08-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2014-12-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2014-08-29 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2015-07-30 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-08-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2015-11-05 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2016-04-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2016-06-09 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2016-11-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2016-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2017-03-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2017-11-21 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2018-09-06 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2018-09-06 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2020-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2019-10-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 2020-06-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 28 | AP | 2021-07-09 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2021-03-23 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2022-10-07 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 18 | Null | 31 |
| SUPPL | 23 | Null | 15 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 28 | Null | 15 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 30 | Null | 6 |
CDER Filings
VIIV HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 204790
[companyName] => VIIV HLTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"TIVICAY","activeIngredients":"DOLUTEGRAVIR SODIUM","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"TIVICAY","activeIngredients":"DOLUTEGRAVIR SODIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"TIVICAY","activeIngredients":"DOLUTEGRAVIR SODIUM","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"06\/12\/2020","submission":"SUPPL-25","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204790s025lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204790s023lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204790s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204790s024lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204790s024lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204790s016s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2018","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204790s016s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2017","submission":"SUPPL-14","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204790s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204790s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2016","submission":"SUPPL-8","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204790Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/22\/2016","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204790s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204790s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204790s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204790s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204790s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204790s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204790lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/12\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204790lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204790Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204790Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204790Orig1S000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"06\/12\/2020","submission":"SUPPL-25","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204790s025lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204790Orig1s025ltr.pdf\"}]","notes":">"},{"actionDate":"10\/24\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204790s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204790Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"03\/24\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204790s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204790orig1s023ltr.pdf\"}]","notes":">"},{"actionDate":"09\/06\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204790s016s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204790Orig1s016s018Ltr.pdf\"}]","notes":">"},{"actionDate":"09\/06\/2018","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204790s016s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204790Orig1s016s018Ltr.pdf\"}]","notes":">"},{"actionDate":"11\/21\/2017","submission":"SUPPL-14","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204790s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204790Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"03\/27\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204790s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204790Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"12\/20\/2016","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/08\/2016","submission":"SUPPL-11","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/09\/2016","submission":"SUPPL-8","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204790Orig1s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204790Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"04\/22\/2016","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204790s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204790Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"11\/05\/2015","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/05\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204790s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204790Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"07\/30\/2015","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/29\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/19\/2014","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204790s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204790Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"05\/12\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204790s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204790Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-06-12
)
)