NDA 214622

QED THERAPEUTICS INC

FDA Drug Application

Application #214622

Documents

• Label: 2021-05-28
• Letter: 2021-06-01
• Review: 2021-06-25

Application Sponsors

NDA 214622

QED THERAPEUTICS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	25MG	2	TRUSELTIQ	INFIGRATINIB
002	CAPSULE;ORAL	100MG	2	TRUSELTIQ	INFIGRATINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-05-28

PRIORITY

Submissions Property Types

ORIG

1

Null

6

TE Codes

001	Prescription	TBD
002	Prescription	TBD

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
        )

)