FRESENIUS KABI USA FDA Approval ANDA 212347

ANDA 212347

FRESENIUS KABI USA

FDA Drug Application

Application #212347

Application Sponsors

ANDA 212347FRESENIUS KABI USA

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION150MG/100ML;450MG/100ML0POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%POTASSIUM CHLORIDE; SODIUM CHLORIDE
002INJECTABLE;INJECTION300MG/100ML;900MG/100ML0POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%POTASSIUM CHLORIDE; SODIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212347
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"150MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"300MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-17
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.