NDA 215904

MARINUS PHARMA INC

FDA Drug Application

Application #215904

Documents

• Label: 2022-03-18
• Letter: 2022-03-22
• Letter: 2022-03-18
• Label: 2022-03-18
• Review: 2022-04-12
• Federal Register Notice: 2022-06-03
• Label: 2022-11-10
• Label: 2022-11-10
• Medication Guide: 2022-11-10
• Letter: 2022-11-10
• Letter: 2022-11-10

Application Sponsors

NDA 215904

MARINUS PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

50MG/ML

0

ZTALMY

GANAXOLONE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2022-03-18	PRIORITY Date of Approval; DEA Scheduling Not Complete
LABELING; Labeling	SUPPL	2	AP	2022-11-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	6

TE Codes

001

Prescription

TBD

CDER Filings

MARINUS PHARMA INC

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(
    [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
        )

)