NIVAGEN PHARMS INC FDA Approval ANDA 213071

ANDA 213071

NIVAGEN PHARMS INC

FDA Drug Application

Application #213071

Application Sponsors

ANDA 213071NIVAGEN PHARMS INC

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS1GM/10ML (100MG/ML)0CALCIUM GLUCONATECALCIUM GLUCONATE

FDA Submissions

UNKNOWN; ORIG1AP2022-10-14STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

NIVAGEN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213071
            [companyName] => NIVAGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCIUM GLUCONATE","activeIngredients":"CALCIUM GLUCONATE","strength":"1GM\/10ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CALCIUM GLUCONATE","submission":"CALCIUM GLUCONATE","actionType":"1GM\/10ML (100MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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