Documents
Application Sponsors
NDA 212937 | FENNEC PHARMACEUTICALS INC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 12.5G;100ML | 0 | PEDMARK | SODIUM THIOSULFATE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2022-09-20 | PRIORITY |
Submissions Property Types
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
)
)