FRESENIUS KABI USA FDA Approval ANDA 212346

ANDA 212346

FRESENIUS KABI USA

FDA Drug Application

Application #212346

Application Sponsors

ANDA 212346FRESENIUS KABI USA

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION5GM/100ML;75MG/100ML0DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%DEXTROSE; POTASSIUM CHLORIDE
002INJECTABLE;INJECTION5GM/100ML;150MG/100ML0DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%DEXTROSE; POTASSIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-10STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212346
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;75MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;150MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-10
        )

)

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