FRESENIUS KABI USA FDA Approval ANDA 206486

ANDA 206486

FRESENIUS KABI USA

FDA Drug Application

Application #206486

Application Sponsors

ANDA 206486FRESENIUS KABI USA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1GM/100ML0MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERMAGNESIUM SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2016-03-07STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206486
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"1GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/07\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-07
        )

)

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