ASTEX PHARMACEUTICALS INC FDA Approval NDA 212576

NDA 212576

ASTEX PHARMACEUTICALS INC

FDA Drug Application

Application #212576

Documents

Label2020-07-07
Letter2020-07-08
Review2020-07-27

Application Sponsors

NDA 212576ASTEX PHARMACEUTICALS INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL35MG;100MG2INQOVIDECITABINE;CEDAZURIDINE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-07-07PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

ASTEX PHARMACEUTICALS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212576
            [companyName] => ASTEX PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"INQOVI","activeIngredients":"DECITABINE;CEDAZURIDINE","strength":"35MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"07\/07\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212576s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/07\/2020","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\\\/2020\\\/212576s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212576Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-07
        )

)

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