KINDOS FDA Approval ANDA 216038

ANDA 216038

KINDOS

FDA Drug Application

Application #216038

Application Sponsors

ANDA 216038KINDOS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS250MG/50ML (5MG/ML)0NELARABINENELARABINE

FDA Submissions

UNKNOWN; ORIG1AP2023-01-10STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

KINDOS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216038
            [companyName] => KINDOS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NELARABINE","activeIngredients":"NELARABINE","strength":"250MG\/50ML (5MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/10\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-10
        )

)

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