FRESENIUS KABI USA FDA Approval ANDA 213523

ANDA 213523

FRESENIUS KABI USA

FDA Drug Application

Application #213523

Documents

Letter2021-04-13

Application Sponsors

ANDA 213523FRESENIUS KABI USA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001INJECTABLE;INJECTION5GM/100ML;74.5MG/100ML;450MG/100ML0POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
002INJECTABLE;INJECTION5GM/100ML;149MG/100ML;450MG/100ML0POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
003INJECTABLE;INJECTION5GM/100ML;224MG/100ML;450MG/100ML0POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
004INJECTABLE;INJECTION5GM/100ML;298MG/100ML;450MG/100ML0POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-03-09STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
004PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213523
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;74.5MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;149MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;224MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;298MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-09
        )

)

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