NIPPON SHINYAKU CO LTD FDA Approval NDA 212154

NDA 212154

NIPPON SHINYAKU CO LTD

FDA Drug Application

Application #212154

Documents

Label2020-08-13
Letter2020-08-13
Review2020-08-31

Application Sponsors

NDA 212154NIPPON SHINYAKU CO LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION250MG/5ML2VILTEPSOVILTOLARSEN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-08-12PRIORITY

Submissions Property Types

ORIG1Null40

CDER Filings

NIPPON SHINYAKU CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212154
            [companyName] => NIPPON SHINYAKU CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VILTEPSO","activeIngredients":"VILTOLARSEN","strength":"250MG\/5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"08\/12\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212154s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/12\/2020","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\\\/2020\\\/212154s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212154Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-08-12
        )

)

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