QED THERAPEUTICS INC FDA Approval NDA 214622

NDA 214622

QED THERAPEUTICS INC

FDA Drug Application

Application #214622

Documents

Label2021-05-28
Letter2021-06-01

Application Sponsors

NDA 214622QED THERAPEUTICS INC

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL25MG2TRUSELTIQINFIGRATINIB
002CAPSULE;ORAL100MG2TRUSELTIQINFIGRATINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-05-28PRIORITY

Submissions Property Types

ORIG1Null6

TE Codes

001PrescriptionTBD
002PrescriptionTBD

CDER Filings

QED THERAPEUTICS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214622
            [companyName] => QED THERAPEUTICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRUSELTIQ","activeIngredients":"INFIGRATINIB","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"TRUSELTIQ","activeIngredients":"INFIGRATINIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"05\/28\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214622s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/28\/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\\\/214622s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214622Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-05-28
        )

)

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