FRESENIUS KABI USA FDA Approval ANDA 212348

ANDA 212348

FRESENIUS KABI USA

FDA Drug Application

Application #212348

Documents

Letter2021-08-16

Application Sponsors

ANDA 212348FRESENIUS KABI USA

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION5GM/100ML;149MG/100ML;225MG/100ML0POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
002INJECTABLE;INJECTION5GM/100ML;149MG/100ML;225MG/100ML0POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-07-30STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

002PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212348
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;149MG\/100ML;225MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;149MG\/100ML;225MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/30\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-30
        )

)

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