TAKEDA PHARMS USA FDA Approval NDA 215596

NDA 215596

TAKEDA PHARMS USA

FDA Drug Application

Application #215596

Documents

Letter2021-11-24
Label2021-11-24

Application Sponsors

NDA 215596TAKEDA PHARMS USA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL400MG0LIVTENCITYMARIBAVIR

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-11-23PRIORITY

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionTBD

CDER Filings

TAKEDA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215596
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIVTENCITY","activeIngredients":"MARIBAVIR","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/23\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215596lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215596lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215596Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-11-23
        )

)

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