NDA 213983

VIIV HLTHCARE

FDA Drug Application

Application #213983

Documents

• Label: 2020-06-15
• Letter: 2020-06-16
• Review: 2020-11-09
• Letter: 2021-03-24
• Label: 2021-03-25
• Label: 2021-07-12
• Letter: 2021-07-13
• Letter: 2022-10-11
• Label: 2022-10-11

Application Sponsors

NDA 213983

VIIV HLTHCARE

Marketing Status

• Prescription: 001

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
        )

)