VIIV HLTHCARE FDA Approval NDA 213983

NDA 213983

VIIV HLTHCARE

FDA Drug Application

Application #213983

Documents

Label2020-06-15
Letter2020-06-16

Application Sponsors

NDA 213983VIIV HLTHCARE

Marketing Status

Prescription001

Application Products

001TABLET;ORAL5MG2TIVICAY PDDOLUTEGRAVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2020-06-12PRIORITY

Submissions Property Types

ORIG1Null7

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
        )

)

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