Documents
Application Sponsors
NDA 215904 | MARINUS PHARMA INC | |
Marketing Status
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
TE Codes
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
)
)