NIVAGEN PHARMS INC FDA Approval ANDA 212117

ANDA 212117

NIVAGEN PHARMS INC

FDA Drug Application

Application #212117

Application Sponsors

ANDA 212117NIVAGEN PHARMS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS50MG/VIAL0DECITABINEDECITABINE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-07STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAP

CDER Filings

NIVAGEN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212117
            [companyName] => NIVAGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DECITABINE","activeIngredients":"DECITABINE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-07
        )

)

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