CTI BIOPHARMA CORP FDA Approval NDA 208712

NDA 208712

CTI BIOPHARMA CORP

FDA Drug Application

Application #208712

Documents

Letter2022-03-01
Review2022-03-29

Application Sponsors

NDA 208712CTI BIOPHARMA CORP

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL100MG0VONJOPACRITINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-02-28PRIORITY

Submissions Property Types

ORIG1Null2

CDER Filings

CTI BIOPHARMA CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208712
            [companyName] => CTI BIOPHARMA CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"VONJO","activeIngredients":"PACRITINIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/208712Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-28
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.