FENNEC PHARMACEUTICALS INC FDA Approval NDA 212937

NDA 212937

FENNEC PHARMACEUTICALS INC

FDA Drug Application

Application #212937

Documents

Label2022-09-20
Letter2022-09-21

Application Sponsors

NDA 212937FENNEC PHARMACEUTICALS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION12.5G;100ML0PEDMARKSODIUM THIOSULFATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-09-20PRIORITY

Submissions Property Types

ORIG1Null2

CDER Filings

FENNEC PHARMACEUTICALS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212937
            [companyName] => FENNEC PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEDMARK","activeIngredients":"SODIUM THIOSULFATE","strength":"12.5G;100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/20\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/212937s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/20\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/212937s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/212937Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-09-20
        )

)

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