PRAXGEN FDA Approval ANDA 213797

ANDA 213797

PRAXGEN

FDA Drug Application

Application #213797

Application Sponsors

ANDA 213797PRAXGEN

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUSEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)0LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUM

FDA Submissions

UNKNOWN; ORIG1AP2021-11-02STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

PRAXGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213797
            [companyName] => PRAXGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOLEUCOVORIN CALCIUM","activeIngredients":"LEVOLEUCOVORIN CALCIUM","strength":"EQ 175MG BASE\/17.5ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-02
        )

)

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