VIIV HLTHCARE FDA Approval NDA 212888

NDA 212888

VIIV HLTHCARE

FDA Drug Application

Application #212888

Documents

Letter2021-01-22
Label2021-01-26

Application Sponsors

NDA 212888VIIV HLTHCARE

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, FILM COATED30MG0CABENUVACABOTEGRAVIR;RILPIVIRINE
002SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR600MG/3ML; 900MG/3ML2CABENUVACABOTEGRAVIR;RILPIVIRINE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG1AP2021-01-21PRIORITY

Submissions Property Types

ORIG1Null33

TE Codes

001PrescriptionTBD
002PrescriptionTBD

CDER Filings

VIIV HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212888
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABENUVA","activeIngredients":"CABOTEGRAVIR;RILPIVIRINE","strength":"400MG\/2ML; 600MG\/2ML","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"CABENUVA","activeIngredients":"CABOTEGRAVIR;RILPIVIRINE","strength":"600MG\/3ML; 900MG\/3ML","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"01\/21\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212888s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212888s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212888Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-01-21
        )

)

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