Documents
Application Sponsors
NDA 214429 | DRUGS FOR NEGLECTED DISEASES INITIATIVE | |
Marketing Status
Application Products
001 | TABLET;ORAL | 600MG | 0 | FEXINIDAZOLE | FEXINIDAZOLE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2021-07-16 | PRIORITY |
Submissions Property Types
CDER Filings
DRUGS FOR NEGLECTED DISEASES INITIATIVE
cder:Array
(
[0] => Array
(
[ApplNo] => 214429
[companyName] => DRUGS FOR NEGLECTED DISEASES INITIATIVE
[docInserts] => ["",""]
[products] => [{"drugName":"FEXINIDAZOLE","activeIngredients":"FEXINIDAZOLE","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"07\/16\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214429s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/16\/2021","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\\\/2021\\\/214429s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214429Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-07-16
)
)