VIIV HLTHCARE FDA Approval NDA 215413

NDA 215413

VIIV HLTHCARE

FDA Drug Application

Application #215413

Documents

Letter2022-03-31
Label2022-03-31
Medication Guide2022-03-31
Review2022-05-12

Application Sponsors

NDA 215413VIIV HLTHCARE

Marketing Status

Prescription001

Application Products

001TABLET, FOR SUSPENSION; ORALEQ 60MG BASE; 5MG; 30MG0TRIUMEQ PDABACAVIR DOLUTEGRAVIR LAMIVUDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2022-03-30PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

VIIV HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215413
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/215413s000lbl.pdf#page=53"]
            [products] => [{"drugName":"TRIUMEQ PD","activeIngredients":"ABACAVIR DOLUTEGRAVIR LAMIVUDINE","strength":"EQ 60MG BASE; 5MG; 30MG","dosageForm":"TABLET, FOR SUSPENSION; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/30\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215413s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/30\/2022","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\\\/2022\\\/215413s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215413Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-03-30
        )

)

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