ANDA 214623

FRESENIUS KABI USA

FDA Drug Application

Application #214623

Application Sponsors

ANDA 214623

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;PERFUSION, CARDIAC

17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML

0

CARDIOPLEGIC IN PLASTIC CONTAINER

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214623
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARDIOPLEGIC IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"17.6MG\/100ML;325.3MG\/100ML;119.3MG\/100ML;643MG\/100ML","dosageForm":"SOLUTION;PERFUSION, CARDIAC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-18
        )

)