Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 5MG | 2 | TIVICAY PD | DOLUTEGRAVIR |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2020-06-12 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 2 | AP | 2021-07-09 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2022-10-07 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 6 |
SUPPL | 3 | Null | 7 |
CDER Filings
VIIV HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 213983
[companyName] => VIIV HLTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"TIVICAY PD","activeIngredients":"DOLUTEGRAVIR SODIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"06\/12\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213983s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/12\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213983s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213983Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-06-12
)
)