MARINUS PHARMA INC FDA Approval NDA 215904

NDA 215904

MARINUS PHARMA INC

FDA Drug Application

Application #215904

Documents

Label2022-03-18
Letter2022-03-22
Letter2022-03-18
Label2022-03-18
Review2022-04-12

Application Sponsors

NDA 215904MARINUS PHARMA INC

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL50MG/ML0ZTALMYGANAXOLONE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-03-18PRIORITY Date of Approval; DEA Scheduling Not Complete

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionTBD

CDER Filings

MARINUS PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215904
            [companyName] => MARINUS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZTALMY","activeIngredients":"GANAXOLONE","strength":"50MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/18\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215904s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/18\/2022","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\\\/2022\\\/215904s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215904Orig1s000ltr.pdf\"}]","notes":"> $(document).ready(function(){ $('[data-toggle=\"popover\"]').popover({ placement : 'top', trigger : 'hover' }); }); Date of Approval; DEA Scheduling Not Complete"}]
            [supplements] => 
            [actionDate] => 2022-03-18
        )

)

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