FRESENIUS KABI USA FDA Approval ANDA 211087

ANDA 211087

FRESENIUS KABI USA

FDA Drug Application

Application #211087

Application Sponsors

ANDA 211087FRESENIUS KABI USA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001INJECTABLE;INJECTION14.9MG/ML0POTASSIUM CHLORIDE 10MEQPOTASSIUM CHLORIDE
002INJECTABLE;INJECTION746MG/100ML0POTASSIUM CHLORIDE 10MEQPOTASSIUM CHLORIDE
003INJECTABLE;INJECTION29.8MG/ML0POTASSIUM CHLORIDE 20MEQPOTASSIUM CHLORIDE
004INJECTABLE;INJECTION2.98GM/100ML0POTASSIUM CHLORIDE 40MEQPOTASSIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-09STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
004PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211087
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE 10MEQ","activeIngredients":"POTASSIUM CHLORIDE","strength":"14.9MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 10MEQ","activeIngredients":"POTASSIUM CHLORIDE","strength":"746MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 20MEQ","activeIngredients":"POTASSIUM CHLORIDE","strength":"29.8MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 40MEQ","activeIngredients":"POTASSIUM CHLORIDE","strength":"2.98GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-09
        )

)

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