DRUGS FOR NEGLECTED DISEASES INITIATIVE FDA Approval NDA 214429

NDA 214429

DRUGS FOR NEGLECTED DISEASES INITIATIVE

FDA Drug Application

Application #214429

Documents

Letter2021-07-19
Label2021-07-20

Application Sponsors

NDA 214429DRUGS FOR NEGLECTED DISEASES INITIATIVE

Marketing Status

Prescription001

Application Products

001TABLET;ORAL600MG0FEXINIDAZOLEFEXINIDAZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-07-16PRIORITY

Submissions Property Types

ORIG1Null6

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
        )

)

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