ANDA 212117

NIVAGEN PHARMS INC

FDA Drug Application

Application #212117

Application Sponsors

ANDA 212117

NIVAGEN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

50MG/VIAL

0

DECITABINE

DECITABINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-12-07

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

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
        )

)