INTL MEDICATION SYS FDA Approval ANDA 203451

ANDA 203451

INTL MEDICATION SYS

FDA Drug Application

Application #203451

Application Sponsors

ANDA 203451INTL MEDICATION SYS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION500MG/ML0DEXTROSE 50%DEXTROSE

FDA Submissions

UNKNOWN; ORIG1AP2021-03-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

INTL MEDICATION SYS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203451
            [companyName] => INTL MEDICATION SYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 50%","activeIngredients":"DEXTROSE","strength":"500MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-26
        )

)

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