Documents
Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | EQ 50MG BASE;300MG | 1 | DOVATO | DOLUTEGRAVIR SODIUM; LAMIVUDINE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2019-04-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-10-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2020-08-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2020-08-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2021-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-03-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2022-01-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2022-01-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2023-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2022-10-07 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 15 | Null | 7 |
CDER Filings
VIIV HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 211994
[companyName] => VIIV HLTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"DOVATO","activeIngredients":"DOLUTEGRAVIR SODIUM; LAMIVUDINE","strength":"EQ 50MG BASE;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/24\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211994s004lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211994s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211994s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211994s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/08\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211994s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"04\/08\/2019","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\\\/2019\\\/211994s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211994Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211994Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"10\/24\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211994s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211994Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"03\/24\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211994s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211994Orig1s004ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-03-24
)
)