CELGENE CORP FDA Approval NDA 214120

NDA 214120

CELGENE CORP

FDA Drug Application

Application #214120

Documents

Label2020-09-01
Letter2020-09-02

Application Sponsors

NDA 214120CELGENE CORP

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL200MG0ONUREGAZACITIDINE
002TABLET; ORAL300MG0ONUREGAZACITIDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2020-09-01PRIORITY

Submissions Property Types

ORIG1Null40

CDER Filings

CELGENE CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214120
            [companyName] => CELGENE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONUREG","activeIngredients":"AZACITIDINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ONUREG","activeIngredients":"AZACITIDINE","strength":"300MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/01\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214120s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214120s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-09-01
        )

)

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